Bexsero® (MenB-4C) Meningitis B Vaccine Clinical Trials, Dosage, Efficacy, Side Effects
GSK's Bexsero® (MenB-4C) vaccine contains proteins from group B Neisseria meningitidis bacteria chosen to protect people against most MenB strains. The U.S. Food and Drug Administration (FDA) initially approved (BL 125546) Bexsero (Meningococcal Group B Vaccine) for intramuscular injection in 2015. The European Medicines Agency (EMA) issued authorization EMEA/H/C/002333 in 2013, and the United Kingdom. The approval of Bexsero was based on the demonstration of the immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains.
Bexsero is FDA-approved for 10- through 25-year-olds, two doses, four weeks apart, to prevent meningococcal group B disease caused by Neisseria meningitidis bacteria. The U.S. Centers for Disease Control and Prevention (CDC) vaccination schedule was posted in 2024. According to the CDC, different meningococcal vaccines protect people against serogroups A, C, W, and Y. In addition, GSK's vaccination schedule was updated in 2024. CDC's Advisory Committee on Immunization Practices recommends routine vaccination based on "shared clinical decision-making."
GSK announced in the first quarter of 2024 that sales for Bexsero were stable at AER and increased by 3% at CER in the quarter, primarily reflecting increased demand in Australia and the recent launch in Vietnam. The global meningococcal vaccines market size is expected to reach USD 4.92 billion by 2030, registering a CAGR of 6.2%.
GSK, based in the U.K., is the producer of Bexsero. DrugBank Accession Number: DB10786. STN: BL 125546. BL 125546/824. ATC code: J07AH09. The FDA removed Warnings and Precautions, Latex (5.3), from the Package Insert on April 26, 2023.
Bexsero Vaccine Dosage
Bexsero is for intramuscular use only. On December 12, 2024, the U.S. CDC endorsed the ACIP's recommended using this new dosing regimen and the same product for all doses. Under the latest recommendations, healthy people ages 16-23 who choose to receive Bexsero based on shared clinical decision-making will receive two doses six months apart. However, if the second dose is given earlier than six months, a third should be given at least four months after the second dose. For people ages 10 years and older at high risk of severe disease, intervals for the three doses are zero, one to two months, and six months. This group includes people with anatomic or functional asplenia, complement component deficiencies, or complement inhibitor use; microbiologists routinely exposed to Neisseria meningitidis isolates; and people at increased risk during an outbreak. High-risk patients would not need to be re-vaccinated if they received doses on the old schedule. They should continue booster vaccination as previously recommended. Clinicians can use a three-dose series of Bexsero for patients looking for more rapid protection.
Bexsero Vaccine Protection
Models show that protection and evolution varied by antigen and that 4CMenB likely elicits antibody-producing long-lived plasma cells. 4CMenB protection from real-world MenB disease persisted at 61.5% four years post-priming and 70.5% four years post-booster.
Bexsero Vaccine Indication
Bexsero is an FDA-approved vaccine to prevent invasive diseases caused by Neisseria meningitidis serogroup B. As the expression of antigens included in the vaccine is epidemiologically variable in circulating B strains, meningococci that express them at sufficient levels are predicted to be susceptible to killing by vaccine-elicited antibodies. Effectiveness against various other group B strains has not been confirmed. Approximately 10% of individuals carry N. meningitidis asymptomatically in their nasopharynx, and close contact, such as coughing or kissing, is typically required for the bacteria to spread from person to person.
Bexsero Vaccine Prevents Gonorrhea
Real-world evidence revealed that the MenB vaccine Bexsero provides cross-protection against gonorrhea. On July 8, 2024, the Journal of Infection published results from a systematic review and meta-analysis. Adjusted VE for OMV vaccines against gonorrhea ranged from 22% to 46%. The pooled VE estimates of OMV vaccines against any gonorrhea infection following the entire vaccine series were 33-34%. The study authors concluded that 4CMenB and other MenB-OMV vaccines show moderate effectiveness against gonorrhea.
On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation recommended a routine targeted vaccination program using the 4CMenB (Bexsero®) to prevent gonorrhea. Receiving two doses of Bexsero, which includes an OMV component, is estimated to reduce the chances of getting gonorrhea by 33%. The 4CMenB vaccine is reported to have efficacy against gonorrhea in 2017 and 2023. In October 2023, Jodie A. Dionne, MD, MSPH, associate professor of medicine at the University of Alabama at Birmingham, stated they had enrolled more than 1,500 participants in a Bexsero National Institute of Allergy and Infectious Diseases sponsored phase 2 clinical trial. In addition, study results published on July 22, 2023, were consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may cross-protect against gonorrhea infection. The DOXYVAC phase 3 clinical study added the 4CMenB (Bexsero) vaccine since gonorrhea and meningitis B organisms are of the Neisseria genus. On April 12, 2022, an observational cohort and case-control study from South Australia found that Bexsero also provides moderate cross-protection against gonorrhea after receiving two doses of Bexsero and is estimated to reduce the chances of getting gonorrhea by 33%. A Retrospective Cohort Study published in 2019 suggested vaccination with MeNZB™ significantly reduced the hospitalization rate from gonorrhea. This study supports prior research indicating possible cross-protection of this vaccine against gonorrhea acquisition and disease in the outpatient setting.
Bexsero Vaccine Ingredients
Apart from active ingredients, the vaccine contains minimal amounts of aluminum, which strengthens and lengthens the immune response to the vaccine, salt (sodium chloride), sugar (sucrose), and an amino acid called histidine, both of which are h used as acidity regulators.
Bexsero Side Effects
Bexsro is contraindicated in cases of hypersensitivity, including severe allergic reactions, to any vaccine component after a previous dose of BEXSERO. The most common side effects of BEXSERO are pain, redness or hardness at the injection site, muscle pain, fatigue, headache, and nausea. Anyone allergic to these ingredients or severely allergic after a previous dose should not receive BEXSERO. Fainting can occur after receiving BEXSERO. For this reason, your healthcare professional may ask you to sit or lie down for 15 minutes after receiving BEXSERO.
Bexsero Immunocompromised
Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even after being vaccinated with BEXSERO. Some individuals with weakened immune systems may have reduced immune responses to BEXSERO.
Bexsero FAQs
Bexsero publishes answers to meningitis questions.
Bexsero Vaccine News
January 5, 2024 - Meningitis B vaccines are being offered to all Prince Edward Island, Canada post-secondary students. The province health department expanded access after new cases were diagnosed in Ontario. "University-aged students are at a higher risk of invasive meningococcal disease," Chief Public Health Office Dr. Heather Morrison informed CBC News.
August 4, 2023 - GSK is developing a pentavalent vaccine, a combination including Bexsero.
March 14, 2023 - GSK's MenABCWY combination vaccine candidate met all 11 primary endpoints of the pivotal phase III clinical trial and was well tolerated with a safety profile consistent with Bexsero.
April 19, 2022 - The BMJ published an article: Meningitis vaccine could protect against gonorrhea, studies find.
April 12, 2022 - The Lancet published a study that concluded complete vaccination with the four-component meningococcal serogroup B vaccine (Bexsero) provided 40% protection against gonorrhea infection compared with no immunization (adjusted prevalence ratio 0.60, 95% CI 0.47-0.77, P<0.0001). This finding indicates that the MenB-4C vaccine could offer cross-protection against Neisseria gonorrhoeae.
October 12, 2017 - The FDA issued STN: BL 125546/189 to GSK.
January 23, 2015 - FDA Clinical Review date.
Bexsero Meningitis B Vaccine Clinical Trials
Bexsero Meningitis B Vaccine Has been tested in over 80 clinical studies.
On February 2, 2023, the NEJM published an Original Article: Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children, that concluded complete vaccination with 4CMenB was found to be effective in preventing invasive disease by serogroup B and non–serogroup B meningococci in children younger than five years of age. On April 12, 2022, The Lancet Infectious Diseases published: Public health impact and cost-effectiveness of gonorrhea vaccination: an integrated transmission-dynamic health-economic modeling analysis. Interpretation - We recommend vaccination against gonorrhea according to risk in sexual health clinics in England with the 4CMenB vaccine be considered.
