Bexsero® (MenB-4C) Meningitis B Vaccine 2023
GSK's Bexsero® (MenB-4C) vaccine contains proteins from group B Neisseria meningitidis bacteria. The combination of proteins was chosen to protect against most MenB strains. The U.S. Food and Drug Administration (FDA) initially approved (BL 125546) Bexsero (Meningococcal Group B Vaccine) suspension for intramuscular injection in 2015. The European Medicines Agency (EMA) issued authorization EMEA/H/C/002333 in 2013. 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 in the USA. BEXSERO is 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. CDC's Advisory Committee on Immunization Practices recommends routine vaccination with a quadrivalent meningococcal conjugate vaccine (MenACWY) for adolescents aged 11 or 12, with a booster dose at age 16. People between 16 to 23 receive the Bexsero vaccine based on "shared clinical decision-making." The CDC's vaccination schedule was posted on February 2023. 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 2023.
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.
On May 12, 2023, GSK confirmed it is working with regulatory agencies to review the supplemental Biologics License Application for Bexsero to ensure full licensure under the Accelerated Approval pathway. GSK announced in July 2023 that meningitis vaccines grew again in Q2 23, primarily driven by Bexsero, the vaccine against meningitis B, with higher sales in Europe mainly from inclusion in National Immunisation Programmes and International due to increased private and public market demand. YTD sales benefitted from the initial stocking of Menveo liquid formulation and higher CDC purchases in the U.S. and demand in anticipation of a Bexsero price increase internationally in Q1 23. The global meningococcal vaccines market size is expected to reach USD 4.92 billion by 2030, registering a CAGR of 6.2%.
UK-based GSK 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 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. Bexsro is contraindicated in cases of hypersensitivity, including severe allergic reactions, to any vaccine component after a previous dose of BEXSERO. Effectiveness against various other group B strains has not been confirmed.
Bexsero and Gonorrhea
The 4CMenB vaccine is reported to have efficacy against gonorrhea in 2017 and 2023. In addition, a study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection 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%.
Bexsero is for intramuscular use only. The recommended immunization series consists of four doses. The primary infant series consists of three doses at 2, 4, and 6 months, followed by a fourth dose (booster). The primary series can also be given at 2, 3, and 4 months of age, but the immune response to the NHBA antigen is lower.
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 used as acidity regulators.
Bexsero Side Effects
The most common side effects of aofBEXSERO 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.
Bexsero publishes answers to meningitis questions.
Bexsero Vaccine News 2023
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.
February 21, 2022 - The U.K. government published the new routine immunization schedule. This schedule includes selected programs and vaccines recommended for individuals with underlying medical conditions.
February 9, 2022 - GSK reported during 2021, Bexsero sales were stable at AER but grew 5% CER to £650 million, reflecting increased market share in the U.S.
September 18, 2021 - The WHO reported 608 suspected cases, including 12 confirmed cases of meningitis, and 161 deaths (case fatality ratio of 26%), have been reported in the Banalia health zone in the Democratic Republic of the Congo. Among these cases, 68% are aged 15 years or older.
September 8, 2021 - The World Health Organization in Africa reported that the Democratic Republic of the Congo had declared a Neisseria meningitidis outbreak in the northeastern Tshopo Province. About 261 suspected cases and 129 deaths have been reported.
August 26, 2021 - GlaxoSmithKline promotes the distinction between the common MenACWY vaccine for adolescents and the separate MenB vaccine for older teens. Lending GSK's "Ask2BSure" campaign is former child actor Soleil Moon Frye, who starred in the popular '80s show "Punky Brewster."
July 28, 2021 - GSK reported financial results. Menveo sales were up 55% AER, 71% CER to £59 million, primarily driven by higher demand in the U.S., partly offset by unfavorable phasing and lower demand internationally.
June 28, 2021 - The U.K. published A Freedom of Information request on a detailed report of the vaccine injuries and deaths of the Bexsero vaccine since it came out in 2016 (FOI 21-364).
December 1, 2020 - Meningococcus group B, the most prevalent strain of the meningococcal infection, is prevented with 79% effectiveness in children and young adults inoculated with the 4CMenB vaccine, also known as Bexsero, according to a new collaborative study from researchers in Portugal and the U.K. and led by the University of Bristol which evaluated the vaccine's performance in a real-world setting.
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.