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Fluarix Quadrivalent Vaccine 2023

GSK plc's Fluarix Quadrivalent is prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the GSK flu vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde, producing a "split virus." Each split-inactivated virus is then suspended. Fluarix Quadrivalent is thimerosal-free.

GSK announced in July 2023 that it has started shipping about 40 million doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2023-24 flu season. This immediately follows a licensing and lot-release approval from the U.S. Food and Drug Administration (FDA). The FDA) announced on March 7, 2023, their recommendation for the 2023-2024 vaccine compositions. CPT code: 90686; STN: BL 125127

Please see full Prescribing Information for FLUARIX QUADRIVALENT and for FLULAVAL QUADRIVALENT.

GSK is a Philadelphia-based, global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Fluarix Quadrivalent Indication

Fluarix Quadrivalent is a vaccine indicated for active immunization to prevent disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Do not administer FLUARIX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any vaccine component, including egg protein, or following a previous dose of any influenza vaccine.

Fluarix Quadrivalent Dosage

The preferred sites for intramuscular injection are the anterolateral thigh for children aged 6 through 11 months and the deltoid muscle of the upper arm for persons aged 12 months and older if muscle mass is adequate. 6 months through 8 years: Not previously vaccinated with influenza vaccine: Two doses (0.5-mL each) at least four weeks apart. Six months through 8 years: Vaccinated with influenza vaccine in a previous season: One or two doses (0.5-mL each) and nine years and older: One 0.5-mL dose.

Fluarix Quadrivalent and COVID-19 Vaccines

The US Centers for Disease Control and Prevention (CDC) previously issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.

Fluarix Quadrivalent Side Effects

Fluarix Quadrivalent is generally well-tolerated; however, if you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS, a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences to a vaccine. Anyone can submit information to VAERS.

Fluarix Quadrivalent News

July 13, 2023 - GSK shipped influenza vaccine doses for the US's 2023-24 flu season.

March 17, 2023 - The CDC reported 134 pediatric influenza-related deaths for the 2022-2023 influenza season.

May 4, 2022 - The WHO reported for week 16 that influenza activity remained low globally, but activity has increased since February 2022 after an initial decrease in January 2022. Detections were mainly influenza A(H3N2) viruses and B/Victoria lineage viruses.

April 8, 2022 - The CDC flu report FluView stated that influenza activity increased nationally this week. The majority of flu viruses detected are A(H3N2).

February 9, 2022 - GSK reported Fluarix/FluLaval sales decreased in 2021 by 7% AER, 2% CER, to £679 million as a result of unfavorable prior period RAR movements in the US, partially offset by higher volume in the US and strong southern hemisphere demand in International.

November 11, 2021 - The WHO reported that influenza detections remain low globally, but among the positive cases, influenza B viruses predominated.

October 16, 2021 - During week 41, the CDC reported that 1.8% of patient visits reported through ILINet were due to ILI. Two jurisdictions experienced moderate activity, while none reported high or very high.

October 7, 2021 - The UK weekly National Influenza reported eight influenza-positive case samples.

September 11, 2021 - The CDC reported that nationwide influenza-like illness continues to be below baselines.

September 4, 2021 - According to the US CDC, influenza virus circulation remains low; therefore, increases in ILI activity are likely due to increased circulation of other respiratory viruses.

August 13, 2021 - Nationwide, during week 31, 2.0% of patient visits reported through ILINet were due to ILI. However, increasing, the percentage of patient visits for ILI remains below the baseline of 2.6% nationally. One region (Region 7) is at its region-specific baseline, while the remaining areas are below their baselines. Influenza virus circulation remains low; therefore, increases in ILI activity are likely due to increased circulation of other respiratory viruses.

July 28, 2021 - GSK announced its financial results. Fluarix/FluLaval sales grew by over 100% AER and CER to £33 million, driven by strong international southern hemisphere demand.

July 23, 2021 - GSK announced it started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2021-22 flu season. "GSK's focus continues to be increasing vaccination rates during the COVID-19 pandemic, and flu vaccination is an integral part of that public health effort," said Judy Stewart, Senior Vice President and Head of US Vaccines at GSK.

July 2, 2021 - The U.S. FDA confirmed, 'We have approved your request submitted and received March 5, 2021, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Influenza Vaccine (Fluarix), manufactured at your Dresden, Germany facility, to include the 2021-2022 United States formulation and associated labeling revisions.'

July 28, 2020 - GSK expects to supply more than 50 million doses of its influenza vaccines for the US market in the 2020-21 season

Fluarix Quadrivalent Clinical Trials

Fluarix Quadrivalent Vaccine has been involved in over 220 clinical studies.

Flu-v Influenza Description 2022

FLU-v is a novel peptide vaccine candidate.

FLU-v is designed to prompt a response not by antibodies but by a separate arm of the immune system—cellular immunity. Cellular immune responses include activity by white blood cells called cytotoxic T lymphocytes (CTLs). Recent research has shown that influenza-specific CTLs can seek out and remove virus-infected cells before and after flu symptoms arise.

The FLU-v vaccine is designed to stimulate the production of these flu-specific CTLs by targeting several proteins inside the virus that do not vary much from strain to strain, meaning that CTL responses against them may be effective against many virus strains.

Flu-v Indication

Flu-v is a synthetic universal flu vaccine candidate offering long-lasting protection across a broad spectrum of influenza viruses.

Flu-v Dosage

Flu-v is administered as a subcutaneous injection in the upper arm.

Flu-v News 2010 - 2022

April 8, 2022 - The CDC FluView report estimates that, so far this season, there have been at least 3.8 million flu illnesses, 38,000 hospitalizations, and 2,300 deaths from flu.

March 13, 2020 -  Nature published results of a Phase 2b clinical trial. 'The results of this study demonstrate that a peptide-based vaccine designed to induce influenza-specific T cell immunity (in the absence of inducing antibody responses against HA) can provide some protection against influenza.'

November 9, 2015 - PepTCell Limited, trading as SEEK, announces a collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to jointly lead a study(1) of SEEK’s universal flu candidate, FLU-v.

December 1, 2010 - SEEK: PepTcell Changes Name due to New Focus and Success

Flu-v Clinical Trials

Flu-v Influenza vaccine candidate continues to be tested in clinical trials.

Dengvaxia® Vaccine Clinical Trials, Dosage, Efficacy, Lab Test, Side Effects

Sanofi Pasteur's Dengvaxia® (CYD-TDV) is a live attenuated tetravalent chimeric vaccine made using recombinant DNA technology by replacing the PrM (pre-membrane) and E (envelope) structural genes of yellow fever attenuated 17D strain vaccine with those from the four dengue serotypes. Dengvaxia is U.S. Food and Drug Administration (FDA)-approved (Clinical Reviewer: Ralph LeBlanc, STN 125682.0) and indicated for preventing dengue virus serotypes 1, 2, 3, and 4. In 2015, Sanofi Pasteur introduced the first dengue vaccine in endemic countries. Sanofi announced in 2017 that people who received  Dengvaxia and have not been previously infected with one of the dengue viruses might be at risk of developing severe dengue if they get dengue after vaccination. Dengvaxia is not approved for use in individuals whose immunization information is unknown.

On May 1, 2019, Dengvaxia was approved (STN: 125682) by the U.S. FDA for use in children 9-16 years old living in an area where dengue is common (such as the U.S. territories of American Samoa, Puerto Rico, and U.S. Virgin Islands), with laboratory-confirmed prior dengue virus infection. On January 22, 2020, the FDA approved the request submitted by Sanofi Pasteur Inc. on July 23, 2019, to supplement the Dengvaxia Biologics License Application. In addition, the FDA confirmed on July 3, 2023, that the Approval Letter for BL 125682/40 was approved on June 30, 2023, and reissued on August 8, 2023, approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. The review of this FDA supplement was associated with the following National Clinical Trial numbers: NCT01373281, NCT01374516, NCT00842530, and NCT01983553.

The World Health Organization (WHO) stated that following the release of the long-term safety data stratified by serostatus on November 29, 2017, a Strategic Advisory Group of Experts on Immunization (SAGE) working group on dengue vaccines concluded that for countries considering vaccination as part of their dengue control program, a "pre-vaccination screening strategy" would be the preferred option, in which only dengue-seropositive persons are vaccinated.

The Lancet Infectious Diseases journal published results from a prospective, longitudinal, population-based cohort study on March 22, 2024. These researchers reported that a single dose of Dengvaxia (CYD-TDV) did not confer protection against virologically confirmed dengue in children with none or one previous DENV infection at baseline. This study's Interpretation is that the risk of developing virologically confirmed dengue after a single dose of CYD-TDV varied by baseline DENV serostatus. In a related Editorial, the authors wrote, 'The findings of Ylade and colleagues emphasize the need to acquire DENV baseline status before rolling out this type of vaccine.'

Dengvaxia - NDC CODE: 49281-605; UNII 75KB2HPX5H; U.S. License No. 1725; EMA: EMEA/H/C/004171

Sanofi Pasteur Inc. (SNY) is the manufacturer of the Dengvaxia vaccine. Sanofi U.S. Headquarters at 55 Corporate Drive, Bridgewater, NJ 08807. And DBA: P.T. Sanofi-Aventis Indonesia.

Denvaxia Vaccine Availability

Dengvaxia is no longer available in the United States, except in Puerto Rico, where it will be available to select children in 2025. In January 2024, Sanofi-Pasteur announced it would cease manufacturing Dengvaxia for children, citing a lack of demand in the global market as the reason for discontinuing production of this vaccine. On June 26, 2024, the U.S. CDC's vaccine committee reviewed two presentations led by Nicholas Bergren, PhD, MBA, and Joshua Wong, MD. Dengvaxia remains a WHO Prequalified Listed vaccine in 2024.

Dengvaxia Pre-Vaccination Test

The U.S. CDC states that proof of a previous dengue infection is required to administer the Dengvaxia vaccine to children and adolescents. Any test used for screening must meet the minimum test performance standards for its results to be considered reliable: sensitivity≥75%, specificity≥98%.

Dengvaxia Vaccine Efficacy

The journal Vaccine published an article on August 22, 2023, concluding that Dengvaxia's efficacy was 56.5 % (95 % CI, 43·8–66·4) and 60.8 % (95 % CI, 52.0–68.0) against symptomatic, virologically confirmed dengue caused by any serotype more than 28 days after the third dose in Asia (2 to 14-year children) [14] and Latin America (9 to 16-year children). 

Dengvaxia Vaccine Price

According to the U.S. CDC, Vaccine for Children for the uninsured through immunization programs costs $95.93 per dose, while the commercial pricing for the Dengvaxia® vaccine is $100.98. Dengvaxia® vaccine is sold in pharmacies in Costa Rica for approximately $130. Additional vaccine price and discount information is posted at InstantRx™. In addition, a study published in 2021 focused on the cost-effectiveness of dengue vaccination in Puerto Rico, which found an incremental cost-effectiveness ratio of USD 122,000 per QALY gained per vaccination.

Dengvaxia Vaccine Indication

Dengvaxia is recommended for routine use by the U.S. CDC's Advisory Committee on Immunization Practices (ACIP). On October 20, 2022, the ACIP meeting reviewed a vaccine presentation and Dengue Epidemiology. On June 24, 2021, the U.S. CDC's Dengue Vaccine Workgroup reviewed the following presentations: Overview; Dengue Vaccine Knowledge and Attitudes in Puerto Rico; Implementation of Dengue Vaccine in Puerto Rico; Dengue Vaccine Evidence to Recommendations Framework; and VFC Resolution Update. In addition, the CDC confirmed on December 17, 2021 - Recommendations of the Advisory Committee on Immunization Practices, U.S. On October 26, 203, Dr. Wilbor Chen's workgroup confirmed about 100 pediatric doses of Dengvaxia had been administered in Puerto Rico. The CDC says Dengvaxia is not approved for use in U.S. travelers who are visiting but not living in an area where dengue is common.

The CDC reported a model predicts that in a moderate transmission scenario (San Juan, PR) with a previous dengue prevalence of 50% in the eligible age group for vaccination, using a serologic screening test with 80% sensitivity and 95% specificity over ten years (vaccinating children aged nine years with 80% of children aged nine years screened), 3,415 hospitalizations would be prevented and an additional 184 hospitalizations would occur; that translates to averting 19 hospitalizations for every further vaccine-associated hospitalization.

Dengvaxia Vaccine Immunocompromised Individuals

Do not administer DENGVAXIA to individuals with severe immunodeficiency or immunosuppression due to disease or therapy.

Dengvaxia Vaccine Pregnancy and Breastfeeding

There have been no specific studies of DENGVAXIA performed among pregnant women. According to the CDC, the increased risk for dengue-related complications in pregnant females has not been explicitly studied in the Dengvaxia trial; the limited number of pregnant females inadvertently vaccinated during the trial had a similar frequency of adverse pregnancy outcomes (e.g., spontaneous abortion, intrauterine death, and stillbirth) as occurred in the control group. However, the number of vaccinated pregnant females was insufficient to determine the possible effect of Dengvaxia on pregnancy.

Data are not available to evaluate the safety of Dengvaxia in breastfeeding infants. Therefore, the developmental and health benefits of breastfeeding should be considered in conjunction with the risk for DENV infection in the mother and infant.

Dengvaxia Vaccine Dosage

The U.S. CDC's ACIP recommended in June 2021 that 3-doses of Dengvaxia be administered six months apart at months 0, 6, and 12 in persons 9-16 years of age with laboratory-confirmed previous dengue virus infection and living in areas where dengue is endemic (common). However, the CDC published updated vaccination schedules for 2022, which do not indicate any Dengvaxia coadministration advisories. On March 29, 2022, the peer-reviewed journal The Lancet reported that a 'CYD-TDV booster one year or two years after the two-dose or three-dose primary vaccination regimen does not elicit a consistent, meaningful, meaningful booster effect against all dengue serotypes in participants who are seropositive for dengue at baseline.'

Dengvaxia Vaccine Limitations

Dengvaxia is a prophylactic, tetravalent, live-attenuated, chimeric viral vaccine built on a yellow fever 17D backbone. Limitations of use: DENGVAXIA is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with the dengue virus. In addition, when an individual is infected with one dengue serotype, subsequent infection with another may result in more intense conditions. For example, researchers from Duke-NUS Medical School reported that the dengue virus serotype 2 (DENV2) changes its shape through Envelope protein mutations to evade vaccines and therapeutics.

Patients must receive a lab test showing a past infection with dengue before receiving the vaccine. Dengvaxia is not for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Before being vaccinated with Dengvaxia, the CDC vaccine committee informs healthcare providers if a patient has dengue symptoms or lives in or has recently traveled to an area with a risk of dengue and has not previously been infected, they are at increased risk for Severe Dengue disease when vaccinated and subsequently infected with the dengue virus. 

From the first administered dose up to month 72, 53 deaths (0.2%) for subjects who received DENGVAXIA and 34 deaths (0.3 %) for subjects who received placebo were reported in 9 of the 12 studies conducted among subjects six through 16 years of age with at least six months follow-up. None of the deaths were considered related to vaccination. Causes of death among subjects were consistent with those generally reported in children and adolescent populations.

Gabriela Paz Bailey, M.D., Ph.D., MSc Dengue Branch, Division of Vector-Borne Diseases, presented the Dengue Vaccine Evidence to Recommendations Framework on June 24, 2021.

Dengvaxia Vaccine Side Effects

Dengvaxia increases the risk of severe dengue in those who experience their first natural infection after vaccination. The most significant adverse event is hospitalization or severe dengue after vaccinating a seronegative person misclassified as a seropositive. Therefore, healthcare professionals must evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not previously been infected with the dengue virus. The most commonly reported side effects of Dengvaxia were headaches, muscle pain, joint pain, fatigue, injection site pain, and low-grade fever. Update CDC precautions included Pregnancy, HIV infection without evidence of severe immunosuppression, and Moderate or severe acute illness with or without fever. Contraindications include severe immunodeficiency (e.g., hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy, or patients with HIV infection who are severely immunocompromised). The safety and efficacy of Dengvaxia have not been assessed in persons with HIV infection. However, ongoing clinical studies estimate the vaccine's use in adults with well-controlled HIV infection.

Dengvaxia Tests

On May 5, 2022, Anitoa Systems announced the availability of an RT-PCR solution for testing the dengue virus. The multiplex test detects several target genes in a sample, which researchers show highly expressed in patients who later develop severe symptoms. In addition, the peer-reviewed journal The Lancet published on May 4, 2022 - Accuracy and efficacy of pre-dengue vaccination screening for previous dengue infection with a new dengue rapid diagnostic test: a retrospective analysis of phase 3 efficacy trials. The OnSite IgG RDT should provide a valuable tool for screening for previous dengue infection at the point of vaccination.

On February 3, 2022, EUROIMMUN announced that its EUROIMMUN® Anti-Dengue Virus NS1 Type 1-4 ELISA (IgG) was cited by the U.S. CDC as part of the two-step testing algorithm guidance for pre-vaccination screening for the Dengvaxia vaccine that is used to prevent future dengue disease. On May 2, 2022, The Lancet published a retrospective analysis of Phase 3 efficacy trials, concluding that the OnSite IgG RDT test should provide a valuable tool for screening for previous dengue infection at the point of vaccination.

Dengvaxia Vaccine Legal Issues

The Philippines' Public Attorney's Office (PAO) has filed seven more civil cases for the families of those who died after reportedly getting doses of Dengvaxia, an anti-dengue vaccine. In a bulletin issued in December 2021, the PAO stated that 75 civil cases involving Dengvaxia had been lodged before the Quezon City Regional Trial Court.

Dengvaxia Vaccine News

March 22, 2024 - A research study published by The Lancet Infectious Diseases investigated the effects of prematurely discontinued CYD-TDV vaccinations on children's susceptibility to the dengue virus.

August 8, 2023 - The U.S. FDA reissued STN: 125682.

June 30, 2023 - The U.S. FDA issued a Supplemental Approval to Sanofi Pasteur, Inc., Attention: Michael F. Stirr.

January 28, 2023 - Pharmacies in Costa Rica offer the Dengvaxia vaccine for over $100 per dose.

October 20, 2022 - The U.S. CDC presented: UPDATE ON DENGVAXIA: EFFICACY, SAFETY, AND IMPLEMENTATION.

June 29, 2022 - A new study published by Science.org concluded, 'These data suggest that E- and NS1-specific Fc functions may serve as correlates of protection, which can be potentially applied toward the design and evaluation of dengue vaccines.'

April 26, 2022 - The Philippines Department of Health launched the Chikiting Bakunation Days. This annual vaccination drive aims to reach at least one million children who have missed out and are yet to receive any routine vaccine.

December 17, 2021 - The U.S. CDC vaccine committee recommended using Dengvaxia with specific restrictions. The vaccine should only be used for those aged 9–16 who live in endemic areas and have evidence with a specific diagnostic test of prior dengue infection.

December 16, 2021 - The JAMA Network published a viewpoint discussing various challenges to broadly deploying the Dengvaxia vaccine.

July 15, 2021 - The media reported Sanofi had sought permission to market the Dengvaxia vaccine in India.

June 24, 2021 - The U.S. CDC's ACIP committee presented the 'Dengvaxia Vaccine Knowledge and Attitudes Survey- Puerto Rico Physicians.' The ACIP voted 14-0 to adopt the new recommendations.

June 24, 2021 - The journal Nature published a study: Evaluation of the extended efficacy of the Dengvaxia vaccine against symptomatic and subclinical dengue infection.... the vaccine's protective effect was concentrated in the first three years following vaccination. Among individuals with the same antibody titer, we found no difference between the risk of subsequent infection or disease between placebo and vaccine recipients, suggesting that antibody titers are a good predictor of protection and disease risk. 

June 1, 2021 - The Manila Public Attorney's Office reported that a 14-year-old boy from Cavite died of complications from the Dengvaxia vaccine.

May 5, 2021 - The U.S. CDC's ACIP presented the importance of a specific test for pre-vaccination screening. ACIP explores whether three doses of Dengvaxia should be administered routinely to persons 9–16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas, such as Puerto Rico.

November 17, 2020 - Study published by The Lancet: A 2-dose CYD-TDV regimen might be an alternative to the licensed 3-dose regimen in dengue seropositive individuals at baseline and aged nine years and older. Vaccination with reduced doses could improve vaccine compliance and coverage, especially in low-resource settings.

November 16, 2020 - Study: Accuracy and efficacy of pre-dengue vaccination screening for previous dengue infection with five commercially available immunoassays: a retrospective analysis of phase 3 efficacy trials. Our findings suggest that these immunoassays could be used for pre-vaccination screening for CYD-TDV as tools to assist risk stratification until more sensitive and convenient tests become available. 

October 16, 2020 - The Philippines Supreme Court has approved the petition to transfer all Dengvaxia-related cases to a single Regional Trial Court.

December 27, 2019 - A study reported on December 27, 2019, that the 'screen and vaccinate' strategy effectively reduces the number of hospitalized and severe dengue cases. 

March 7, 2019 - The U.S. FDA approved the use of Dengvaxia for children ages 9-16.

December 19, 2018 - The European Commission has granted marketing authorization for Dengvaxia®.

September 7, 2018 - The WHO issued a paper on dengue vaccines.

February 1, 2018 - Editorial published by The Lancet: The dengue vaccine dilemma.

October 4, 2016 - Sanofi Pasteur announced that Dengvaxia had received market approval in Mexico, the Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand, and Singapore.

December 23, 2015 - The Philippines became the first Asian country to approve the commercial sale of Dengvaxia. In April 2016, the Department of Health launched the dengue vaccination campaign in central Luzon, Calabarzon, and Metro Manila, where about 700,000 individuals received at least one vaccine dose.

September 14, 2014 - The Lancet: the past decade has also seen an upsurge in research on dengue virology, pathogenesis, and immunology, and the development of antivirals, vaccines, and new vector-control strategies that can positively impact dengue control and prevention.

Dengvaxia Dengue Vaccine Clinical Trials

Dengvaxia is currently involved in several different clinical trials.

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, followed by 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 U.S. FDA-approved for individuals aged 10 through 25 years. Two doses are given four weeks apart to prevent meningococcal group B disease caused by the Neisseria meningitidis bacteria. The U.S. Centers for Disease Control and Prevention (CDC) vaccination schedule was posted in 2025. According to the CDC, different meningococcal vaccines protect against serogroups A, C, W, and Y. In addition, GSK's vaccination schedule was updated in 2024. The CDC's Advisory Committee on Immunization Practices recommends routine vaccination based on "shared clinical decision-making."

In the United Kingdom (UK), the Joint Committee on Vaccination and Immunisation (JCVI) states that only the licensed 4-component vaccine currently available in the UK, Bexsero®, manufactured by GSK, is authorised for the prevention of meningococcal disease in individuals aged 2 months and older. An analysis led by Imperial College London has suggested the vaccine known as 4CMenB could avert up to 100,000 cases of gonorrhoea and save the NHS over £7.9 million over the next decade. On May 21, 2025, the UK's NHS and local government announced the world-first vaccine program to prevent gonorrhoea. On November 10, 2023, the JCVI recommended a routine targeted vaccination program using the 4CMenB (Bexsero) to prevent gonorrhea. Two doses of Bexsero, which includes an OMV component, are estimated to reduce the chances of getting gonorrhea by 33%. On August 4, 2025, the UK began offering 4CMenB, a vaccine against gonorrhoea, in sexual health clinics in England and Wales to those at the highest risk of infection.

GSK, based in the UK, is the producer of Bexsero. DrugBank Accession Number: DB10786. STN: BL 125546. BL 125546/824. ATC code: J07AH09. The FDA removed the Warnings and Precautions section, including the subsection on Latex (5.3), from the Package Insert on April 26, 2023.

Bexsero Vaccine Prevents Gonorrhea

The 4CMenB vaccine was reported to be effective against gonorrhea in 2013. Real-world evidence published in July 2024 has shown that the MenB vaccine Bexsero offers cross-protection against gonorrhea. In the UK, the NHS and local government in England and Wales are rolling out a world-first vaccine programme in 2025 to prevent gonorrhoea. 

In June 2025, Spain became the first jurisdiction in the world to implement a structured public health programme to prevent gonorrhoea through vaccination.

On May 22, 2025, a systematic review and meta-analysis evaluated the protection offered by OMV-based vaccines against gonorrhea. The study demonstrated a significant reduction of 30 % in gonorrhea diagnoses with OMV-based vaccines. On July 8, 2024, the Journal of Infection published results from a systematic review and meta-analysis on Outer Membrane Vesicles (OMV) vaccines against gonorrhea, with efficacy ranging 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.

In October 2023, Jodie A. Dionne, MD, MSPH, an associate professor of medicine at the University of Alabama at Birmingham, announced that they had enrolled more than 1,500 participants in a Phase 2 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases. In addition, study results published on July 22, 2023, were consistent with the findings of other studies 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 included the 4CMenB (Bexsero) vaccine, as gonorrhea and meningitis B organisms are part of the Neisseria genus. 

In 2024, Australia launched a multicentre, randomised, double-blinded, placebo-controlled trial with a 24-month follow-up. The project will compare the efficacy of the four-component 4CMenB vaccine (a vaccine licensed for the prevention of meningococcal B disease and marketed as Bexsero) with a placebo for the prevention of N. gonorrhoeae infection. 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 two doses of the vaccine, estimated to reduce the risk of gonorrhea by 33%. 

A 2019 retrospective cohort study suggested that vaccination with MeNZB significantly reduced the rate of hospitalization for gonorrhea. This study supports prior research indicating that this vaccine may offer possible cross-protection against gonorrhea acquisition and disease in the outpatient setting.

Bexsero Vaccine Dosage

Bexsero is for intramuscular use only. On December 12, 2024, the U.S. CDC endorsed the ACIP's recommendation to use this new dosing regimen and the same product for all doses. According to the latest recommendations, healthy individuals aged 16-23 who opt to receive Bexsero through shared clinical decision-making will receive two doses, administered six months apart. However, if the second dose is given more than 6 months after the first, a third should be given at least 4 months after the second. For individuals aged 10 years and older at high risk of severe disease, the intervals between the three doses are 0, 1-2 months, and 6 months. This group includes individuals with anatomic or functional asplenia, complement component deficiencies, or those using complement inhibitors; microbiologists routinely exposed to Neisseria meningitidis isolates; and individuals 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 long-lived antibody-producing 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 immunization varies epidemiologically across circulating B strains, meningococci that express them at sufficient levels are predicted to be susceptible to killing by vaccine-elicited antibodies. The 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.

Meningitis Diagnosis, Treatment, and Care Guidelines

The WHO published updated guidelines on meningitis on April 10, 2025. The 2024 U.S. CDC Yellow Book highlights meningitis vaccine options.

Bexsero Vaccine Ingredients

Apart from the active ingredients, the vaccine contains minimal amounts of aluminum, which enhance and prolong the immune response. It also contains sodium chloride (salt), sucrose (sugar), and histidine, an amino acid used as an acidity regulator.

Bexsero Side Effects

Bexsero 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 who has experienced severe allergic reactions 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 those receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at an increased risk of invasive disease caused by Neisseria meningitidis group B, even after vaccination 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

August 4, 2025 - Consultant epidemiologist at the UK Health Security Agency, Dr Sema Mandal, said: This roll-out is hugely welcome as we're currently seeing very concerning numbers of gonorrhoea, including even more worryingly antibiotic-resistant gonorrhoea. The vaccine will provide much-needed protection to those who need it most, making the UK a world leader in the fight against gonorrhoea.

May 21, 2025 - NHS England's National Director for Primary Care and Community Services, Dr Amanda Doyle, said: "The launch of a world-first routine vaccination for gonorrhoea is a huge step forward for sexual health and will be crucial in protecting individuals, helping to prevent the spread of infection, and reducing the rising rates of antibiotic-resistant strains of the bacteria."

January 5, 2024—Meningitis B vaccines are offered to post-secondary students on Prince Edward Island, Canada. The province's 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 Officer 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. It was well tolerated and had a safety profile consistent with Bexsero.

April 19, 2022: The BMJ published an article titled "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 suggests that the MenB-4C vaccine may provide 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, which concluded that 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 being considered.