Bexsero® Meningitis B Vaccine Description - 2022
GSK's Bexsero® vaccine contains proteins from group B Neisseria meningitidis bacteria. The combination of proteins was chosen to protect against most MenB strains. Bexsero (Meningococcal Group B Vaccine) suspension for intramuscular injection was initially approved by the U.S. FDA in 2015. 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 to prevent meningococcal group B disease (meningitis B) 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. And for people between 16 to 23 receive the Bexsero vaccine based on "shared clinical decision-making." The CDC's 2022 vaccination schedule was posted on February 17, 2022. According to the CDC, different meningococcal vaccines are available that protect people against serogroups A, C, W, and Y. The GSK vaccination schedule was updated in 2021, and the European Medicines Agency (EMA) issued authorization EMEA/H/C/002333 in 2013.
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.
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 component of the vaccine or after a previous dose of BEXSERO. Effectiveness against various other group B strains has not been confirmed.
Bexsero and Gonorrhea
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 study included 6,641 recipients of 4CMenB matched to 26,471 recipients of MenACWY. During follow-up, gonorrhea incidence rates per 1000 person-years (95% CI) were 2.0 (1.3-2.8) for recipients of 4CMenB and 5.2 (4.6-5.8) for recipients of MenACWY. In adjusted analyses, gonorrhea rates were 46% lower among recipients of 4CMenB vs MenACWY (HR [95% CI] 0.54 [0.34-0.86]), but chlamydia rates were similar between vaccine groups (HR [95% CI] 0.98 [0.82-1.17]).
Evidence that the MeNZB and four-component serogroup B meningococcal (4CMenB) vaccines can also offer protection against gonorrhea has created interest in using 4CMenB for this purpose and for developing gonorrhea-specific vaccines. An observational study of 16-23-year-olds in New York City and Philadelphia from 2016-to 2018 indicates receiving two doses of the meningitis vaccine 4CMenB provides 40% protection against gonorrhea. Outer membrane vesicle meningococcal serogroup B vaccines might be protective against gonorrhea.
Bexsero is for intramuscular use only. The recommended immunization series consists of four doses. The primary infant series consists of three doses, given at 2, 4, and 6 months of age, 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 these ingredients: Aluminium 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 associated with BEXSERO are pain, redness or hardness at the injection site, muscle pain, fatigue, headache, and nausea. Anyone allergic to these ingredients or who had a severe allergic reaction after a previous dose should not receive BEXSERO.
Bexsero publishes answers to meningitis questions.
Bexsero News For 2020 - 2022
April 27, 2022 - GSK reported meningitis vaccine sales grew 12% AER, 12% CER% to £212 million, mainly driven by Bexsero (22% AER, 23% CER to £163 million), reflecting higher U.S. CDC purchasing.
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 vaccination (adjusted prevalence ratio [APR] 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 2022 routine immunization schedule. This schedule includes selected programs and additional 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 a total of 608 suspected, including 12 confirmed cases of meningitis, and 161 deaths (case fatality ratio of 26%), have been reported in the Banalia health zone of 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 north-eastern Tshopo Province. About 261 suspected cases and 129 deaths have been reported.
August 26, 2021 - GlaxoSmithKline is promoting 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 in International.
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.
Bexsero Meningitis B Vaccine Clinical Trials
Bexsero Meningitis B Vaccine Has been tested in over 80 clinical studies.