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Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

Clinical Trial Phase II:

Clinical Trial Phase III:

Consistency Study of GlaxoSmithKline Biologicals' MMR Vaccine (Priorix) Comparing Immunogenicity and Safety to Merck M-M-R II

Clinical Trial Phase IV:

Search for the Measles Vaccine Virus Excretion in Breast Milk of Breastfeeding Women After Postpartum Vaccination With MMR

Lab Test:

Condition:

Availability Link:

Last Reviewed:

Tuesday, November 18, 2025 - 05:40

Brand:

Priorix

CPT Code:

90707

Accession Number:

DB10317

Status:

Description of Ingredients

Manufacturer Country ID:

Kosher:

Yes

Side Effects:

Warnings and Precautions

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Cell Line Production:

Chick embryo cell culture

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United States of America

Europe

Prevnar 13 Pneumococcal Vaccine

Prevnar 13 Pneumococcal Vaccine Description For 2022

Pfizer Inc.'s Prevnar 13 is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 protein.

PCV13 (pneumococcal conjugate vaccine) protects against 13 of the approximately 90 types of pneumococcal bacteria that can cause the most serious types of pneumococcal disease, including pneumonia, meningitis, and bacteremia. However, Prevnar 13 does not protect against diseases caused by S. pneumoniae serotypes that are not in the vaccine.

The U.S. FDA issued its approval for Prevnar 13 in 2010. In July 2016, the FDA expanded the age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older.

Prevnar 13 Pneumococcal Vaccine Indication

Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, an infection of the lungs. Pneumococcal bacteria are one of the most common causes of pneumonia, says the U.S. CDC.

Prevnar 13 is a vaccine indicated in children 6 weeks through 17 years (before 18th birthday) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In addition, for children 6 weeks through 5 years of age (before the 6th birthday) to prevent otitis media caused by 7 of the 13 serotypes in the vaccine.

In 2014, the ACIP recommended that older adults receive the 13-valent pneumococcal conjugate vaccine (PCV13) first, then the PPSV23 at least 1 year later. Since then, widespread childhood vaccination with PCV13 and its predecessor, the 7-valent pneumococcal conjugate vaccine, have “led to sharp declines in pneumococcal disease among unvaccinated children and adults,” according to the ACIP’s review of the evidence.

Based on that review, the ACIP voted to remove the recommendation for routine use of PCV13, followed by PPSV23 in this senior population. “Incidence of PCV13-type disease has been reduced to historically low levels among adults aged ≥65 years through indirect effects from pediatric PCV13 use,” the authors wrote. The PPSV23 vaccine contains 12 serotypes in common with PCV13 and an additional 11 serotypes, for which there are no indirect effects from PCV13 use in children.

Additionally, on February 18, 2022, ACIP voted to remove PCV13 from the list of recommended vaccines for adults. The new recommendation now states that adults ≥65 years and adults 18-64 with certain medical conditions who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive 1 dose of PCV15 or 1 dose of PCV20. If PCV15 is used, this should be followed by a dose of PPSV23.

Prevnar 13 Pneumococcal Vaccine Dosage

Prevnar 13 is administered as an intramuscular injection only. Visit Pfizer Prevnar 13 for detailed prescribing information.

Prevnar 13 Pneumococcal Vaccine News For 2019 - 2022

July 28, 2022 - Pfizer reported the Prevnar family of vaccines was up 41% operationally in the second quarter of 2022 compared to the second quarter of 2021.

February 21, 2022 - The UK Health Agency published the 2022 complete immunization schedule. This schedule recommends children at 12 weeks receive Prevnar 13.

February 18, 2022 - The U.S. CDC published new immunizations schedules for both Children and Adults.

February 8, 2022 - Pfizer Inc. reported Prevnar / Prevenar 13 & 20 global sales decreased 25% operationally, driven by a 27% decline in the U.S. primarily due to unfavorable timing of government purchases for the pediatric indication and disruptions to healthcare activity related to COVID-19, and a 24% operational decline outside the U.S. primarily due to the impact of increased adult uptake in the prior-year period from greater vaccine awareness for respiratory illnesses.

November 11, 2021 - World Pneumonia Day, November 12, 2021, will address the future of pneumonia prevention.

July 28, 2021 - Pfizer reported financial results. Prevnar 13 was up 34% in the USA, driven by 35% growth in the pediatric indication primarily due to higher levels of healthcare activity and wellness visits compared to the prior-year quarter, which was heavily impacted by COVID-19-related mobility restrictions and limitations, and favorable timing of government purchases, partially offset by a lower year-over-year birth rate, and 24% growth in the adult indication, which was primarily driven by higher levels of healthcare activity compared to the prior-year quarter, partially offset by the impact of a lower remaining eligible unvaccinated population.

March 10, 2021 - Pneumonia vaccine may affect the course of COVID-19. "Kaiser Permanente members who received the PCV13 vaccine appeared to be diagnosed with COVID-19 less often, and when they were, they seemed to have less severe outcomes, overall," said the senior author, Sara Y. Tartof, Ph.D., MPH, a scientist with the Kaiser Permanente Southern California Department of Research & Evaluation.

November 27, 2019 – Pneumococcal vaccination recommendations have undergone several changes in recent years, confusing those who need to select a preventive vaccine.

October 15, 2019 – A new study has found a bacterial infection that can lead to pneumonia or meningitis is linked to weakened immune systems in children.

September 9, 2019 – Pfizer announced positive preliminary results of a Proof-of-Concept Phase 2 clinical study assessing its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077.

Prevnar 13 Pneumococcal Vaccine Clinical Trials

Prevnar 13 has been involved in hundreds of clinical trials.

0 min read

Manufacturer:

Pfizer

Reviewer:

Natasha Gildersleeve PharmD

Holly Lutmer PharmD

Vaccine:

Prevnar 13 Pneumococcal Vaccine

VIS:

Generic:

PCV13

Drug Class:

Vaccine

Find Price:

Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

Clinical Trial Phase I:

Clinical Trial Phase III:

Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

Clinical Trial Phase IV:

13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

Lab Test:

CDC

Condition:

Pneumococcal

Last Reviewed:

Thursday, July 28, 2022 - 14:15

Brand:

Prevnar 13

CPT Code:

90670

Accession Number:

DB10287

Status:

Manufacturer Country ID:

Kosher:

Yes

Halal:

Yes

Side Effects:

Adverse Reactions

Ingredients:

Prevnar 13 Ingredients

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UNII:

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Pneumovax 23 Pneumococcal Vaccine

Pneumovax®23 Vaccine 2022

Merck's PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) is a vaccine that can help protect against infection by 23 types of pneumococcal bacteria, common and often cause serious illnesses. Pneumovax 23 vaccine contains 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

On October 23, 2020, a study published by PLOS concluded 'That PPV23 vaccination provides moderate long-term protection against hospitalization with PPV23 serotype pneumonia. And, PPV23 vaccination may continue to have an important role in national pneumococcal immunization policies, including the possibility of revaccination of older adults.' In a group of 2,357 patients (717 PPV23 cases, 1,640 controls) with an average time of 10 years since PPV23 vaccination, we estimated the VE of PPV23 against PPV23 serotype pneumonia to be 24% after adjustment for patient factors (95% CI 5%–40%, p = 0.02).

The U.S. Centers for Disease Control and Prevention published on January 28, 2022, newly simplified recommendations for pneumococcal vaccination in the elderly and immunocompromised. The changes were published in the Morbidity and Mortality Weekly Report. Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Merck Sharp & Dohme Corp. is an American multinational pharmaceutical company and one of the world's largest pharmaceutical companies.

Pneumovax 23 Indication

The global prevalence of pneumococcal disease, an infection caused by Streptococcus pneumoniae, is evolving, says the U.S. CDC. Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumonia (when it is confined to the lungs), sinusitis, and otitis media (middle ear infection); and invasive pneumococcal illnesses such as bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and meningitis.

The pneumococcal disease includes pneumococcal infections of the lung, blood, and coverings of the brain and spinal cord. Pneumovax 23 will not prevent disease caused by capsular pneumococcus types other than those contained in the vaccine. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Additionally, the U.S. CDC recommends for people with certain chronic conditions such as diabetes, heart disease, or COPD and are 19 to 64 years old, 1 dose of PCV15 followed by PNEUMOVAX 23 or 1 dose of PCV20. Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any vaccine component. Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness. Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or greater severity of reactions in some older individuals cannot be ruled out. Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Pneumovax 23 Dosage

Pneumovax 23 is administered as an intramuscular or subcutaneous injection only. Pneumovax 23 is for people 50 years of age and older and is approved for persons aged ≥2 years who are at increased risk for pneumococcal disease. And if you are 65 years or older, the U.S. CDC recommends either one dose of PCV15 followed by Pneumovax 23 or one dose of Prevnar 20.

Intervals between PCV and PPSV23. Findings from eight immunogenicity studies that evaluated the immune response after a sequence of 7-valent PCV, PCV13, or PCV15 followed by PPSV23 administered at intervals of 2, 6, or 12 months or 3–4 years were reviewed (16–18,25–29). Three studies comparing intervals ranging from 2 to 6 months between administration of PCV and PPSV23 found no significant difference in immunogenicity measured after PPSV23 receipt, although reactogenicity tended to be higher with shorter intervals (25–29). In a study that compared antibody responses to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 1 year apart, the immune responses following PPSV23 were significantly lower compared with the responses after a dose of PCV13 for eight of 12 common serotypes. In another study that compared antibody response to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 approximately 4 years apart, the immune responses following PPSV23 were significantly higher for seven of 12 common serotypes (26). These findings suggested that longer intervals between administration of PCV and PPSV23 might improve immunogenicity in immunocompetent adults, although a direct comparison between a 1- versus 4-year interval was not made.

Pneumovax 23 Sales in 2021

Merck & Co. reported on February 3, 2022, lower sales of PNEUMOVAX 23, which declined 14% to $292 million, primarily driven by lower demand in the U.S.

Pneumovax 23 News 2021 - 2022

November 11, 2021 - This year's World Pneumonia Day theme is Stop Pneumonia/Every Breath Counts.

June 9, 2021 - As reported by Barron's, the U.S. Food and Drug Administration approved Pfizer's updated pneumococcal vaccine (Prevnar 20) for adults late Tuesday in a development that positions the drug giant for a battle with Merck as both hope to win supremacy in the lucrative market.

April 29, 2021 - Merck confirmed Pneumovax 23 sales decreased by 36% last year.

October 23, 2020 - A case-control test-negative design study: Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against vaccine serotype pneumococcal pneumonia in adults. In establishing an established national childhood PCV13 vaccination program, PPV23 vaccination of clinical at-risk patient groups and adults aged ≥65 years provided moderate long-term protection against hospitalization with PPV23 serotype pneumonia. These findings suggest that PPV23 vaccination may continue to have an important role in adult pneumococcal vaccine policy, including the possibility of revaccination of older adults.

September 25, 2020 - The U.S. FDA approved Merck's request submitted and received November 26, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine, Polyvalent, PNEUMOVAX® 23 manufactured at your West Point, Pennsylvania facility to update the package insert to include data on the sequential administration of Prevnar 13® and PNEUMOVAX® 23 in Sections 6.1 Clinical Trials Experience and 14.2 Immunogenicity.

July 20, 2020 - Time for a third-generation pneumococcal conjugate vaccine.

June 22, 2020 - Merck announced results from two initial Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX ® 23 in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases online digital library.

January 31, 2020 - Updated Pneumococcal Vaccine Recommendations for Older Adults.

November 26, 2019 - The U.S. FDA stated: 'We have approved your request submitted and received June 4, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine Polyvalent (PNEUMOVAX®23) manufactured at West Point, Pennsylvania. We hereby approve the draft package insert labeling submitted under Amendment 5001, dated November 8, 2019.'

Pneumovax 23 Vaccine Clinical Trials

Mercks' Pneumovax 23 has been in numerous clinical trials to test the safety, tolerability, and immunogenicity.

0 min read

Manufacturer:

Merck

Reviewer:

Natasha Gildersleeve PharmD

Holly Lutmer PharmD

Vaccine:

Pneumovax 23 Pneumococcal Vaccine

VIS:

Availability:

Worldwide

Generic:

Pneumococcal Vaccine

Drug Class:

Vaccine

Find Price:

A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Adults

Clinical Trial Phase I:

Clinical Trial Phase II:

Study to Evaluate the Response Rate to the Licensed Pneumovax 23 in Elderly Population

Clinical Trial Phase III:

Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participant

Clinical Trial Phase IV:

Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

Condition:

Pneumococcal

Last Reviewed:

Tuesday, June 21, 2022 - 07:40

Brand:

Pneumovax 23

CPT Code:

90732

Accession Number:

DB10327

Status:

Manufacturer Country ID:

Side Effects:

Warnings and Precautions

Ingredients:

PNEUMOVAX 23 Description

Countries:

USA

Canada

UNII:

313LJP87ET

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PedvaxHIB Vaccine

PedvaxHIB Description 2022

PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate

PedvaxHIB Indication

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. PedvaxHIB should not be used in infants <6 weeks of age.

PedvaxHIB Dosage

Age (months) at First DosePrimaryAge (months) at Booster DoseDose

2 to 10 2 doses, 2 months apart 12 to 15 0.5 mL

11 to 14 2 doses, 2 months apart — 0.5 mL

15 to 71 1 dose — 0.5 mL

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Manufacturer:

Reviewer:

Vaccine:

VIS:

Generic:

Haemophilus b Conjugate Vaccine

Drug Class:

Vaccine

Find Price:

Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared

Clinical Trial Phase III:

Clinical Trial Phase IV:

Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and D

Condition:

Hib Haemophilus influenzae type B

Brand:

PedvaxHIB

CPT Code:

90647

Accession Number:

DB10342

Status:

Description of Ingredients

Manufacturer Country ID:

Side Effects:

Precautions

Ingredients:

Countries:

USA

UNII:

LUY6P8763W

Rate Vaccine:

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NanoFlu Influenza Vaccine

NanoFlu™ Vaccine Description

Novavax, Inc.'s NanoFlu™ is a vaccine candidate that is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced in an Sf9 insect cell-baculovirus system. NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type virus HA sequences. NanoFlu contains Novavax's patented saponin-based Matrix-M adjuvant, which is potent, well-tolerated, and stimulates high-quality and durable antibody responses and multifunctional CD4 and CD8 T-cell responses. Recombinant seasonal influenza vaccines have an essential advantage over other flu shots: once licensed for commercial sale, large quantities of vaccines can be manufactured cost-effectively without using the live influenza virus or eggs, says Novavax.

The Lancet published on September 23, 2021: 'Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomized controlled trial.'. NanoFlu showed potent induction of polyfunctional antigen-specific CD4+ T-cells against A/H3N2 and B/Victoria strains, with a 126–189% increase in various post-vaccination cell-mediated immunity markers as compared to Fluzone Quadrivalent. Interpretation - qNIV was well tolerated and produced qualitatively and quantitatively enhanced humoral and cellular immune response in older adults compared with IIV4. qNIV might improve the effectiveness of seasonal influenza vaccination, and future studies to show clinical efficacy are planned. The manuscript was previously posted to the medRxiv preprint server in August 2020.

Maryland-based Novavax, Inc. (Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.

NanoFlu Vaccine Indication

NanoFlu is indicated to prevent serious diseases caused by influenza in older adults. In recent years, it's estimated that up to 85 percent of seasonal flu-related hospitalizations and deaths have occurred in people 65 years and older. It is further estimated that influenza attacks between 5% and 10% of adults and 20% to 30% of children each year, causing significant levels of illness, hospitalization, and death. The NanoFlu vaccine demonstrated significantly stronger and broader immune responses against homologous and heterologous influenza strains, including a series of "drift" strains that evolved over a decade of influenza seasons. In addition, a preclinical challenge study showed that NanoFlu was protective against both a homologous virus and a ten-year-old drifted strain.

NanoFlu Vaccine Dosage

The NanoFlu vaccine candidate is administered as an intramuscular injection.

COVID-NanoFlu™ Combination Vaccine

Novavax's COVID-NanoFlu™ Combination Vaccine combines the company's recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccine candidates with Matrix-M™ adjuvant in a single formulation. Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. In addition, in preclinical studies, the COVID-NanoFlu Combination Vaccine showed robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein with Matrix-M adjuvant playing a key role.

NanoFlu Vaccine News

November 1, 2021 - NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax's' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

September 23, 2021 - "Despite high vaccination rates, limitations in the effectiveness of existing influenza vaccines leave significant disease burden unaddressed, particularly in older adults," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "These encouraging results reflect NanoFlu's promise, especially as we currently have a combination COVID-19-influenza vaccine under evaluation for protection against two life-threatening diseases simultaneously."

October 15, 2021 - Novavax, Inc. announced that Vivek Shinde, M.D., Vice President, Clinical Development, will deliver a presentation during the World Vaccine Congress Europe 2021. A topic of discussion will be Novavax's COVID-NanoFlu™ Combination Vaccine, which combines the company's recombinant nanoparticle protein-based COVID-19 and NanoFlu™ vaccine candidates with Matrix-M™ adjuvant in a single formulation.

September 23, 2021 - Novavax, Inc. announced complete results from a pivotal Phase 3 clinical trial of NanoFlu in The Lancet Infectious Diseases. In the thorough analysis, NanoFlu was well-tolerated and produced significantly enhanced humoral and cellular immune responses versus the comparator vaccine.

September 8, 2021 - Novavax, Inc. announced the enrollment of participants in a Phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax's NanoFlu seasonal influenza and COVID-19 vaccines. Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. In preclinical studies, the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role.

May 10, 2021 - Novavax, Inc. announced positive preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate. The preclinical study found that the combination of NanoFlu/NVX-CoV2373 (qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in ferrets.

March 1, 2021 - Novavax, Inc. announced that they continue to advance the NanoFlu program, including exploring a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting.

November 9, 2020 - Novavax, Inc. announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer. Executive Vice President John Trizzino, who previously served as CFO, will become the Chief Commercial Officer while continuing as Chief Business Officer.

October 13, 2020 - Novavax, Inc. announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company's influenza vaccine candidate, through global licensure, as well as the exploration of a combined influenza/COVID-19 vaccine that could be used in a post-pandemic setting. In addition, Novavax announced the results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intended to seek regulatory approval from the U.S. Food and Drug Administration under the accelerated approval pathway previously granted to the company.

January 15, 2020 - Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Designation for NanoFlu.

October 15, 2019 - Novavax, Inc. announced initiating a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over.

August 5, 2019 - Novavax Reaches Agreement with the U.S. FDA on Pivotal Phase 3 Trial Design for NanoFlu.

January 03, 2019 - Novavax announced Positive Phase 2 NanoFlu Results in Older Adults.

September 19, 2017 - A Phase 1/2 clinical trial of our nanoparticle seasonal influenza vaccine candidate, including our proprietary Matrix-M adjuvant ("NanoFlu™") in older adults.

NanoFlu Vaccine Clinical Trials

Novavax continues to test its influenza candidate, NanoFlu, in clinical trials.

0 min read

Manufacturer:

Reviewer:

Vaccine:

NanoFlu Influenza Vaccine

VIS:

Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant

Availability:

TBD

Generic:

Flu vaccine

Clinical Trial:

https://clinicaltrials.gov/ct2/results?cond=nanoflu&term=novavax&cntry=&state=&city=&dist=

Drug Class:

Recombinant quadrivalent vaccine

Clinical Trial Phase II:

Clinical Trial Phase III:

Phase 3 Pivotal Trial of NanoFlu™ in Older Adults

Lab Test:

CDC

Condition:

Influenza

Last Reviewed:

Friday, December 8, 2023 - 21:40

Brand:

NanoFlu

Status:

Candidate

Manufacturer Country ID:

Side Effects:

Phase 3 study

Ingredients:

2020 study

Cell Line Production:

Sf9 insect cell-baculovirus system

Mosquirix RTS,S/AS01e Malaria Vaccine

Mosquirix™ (RTS,S/AS01e) Malaria Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

GSK's Mosquirix™ RTS,S/AS01e (RTS,S) is a recombinant malaria vaccine with the P. falciparum circumsporozoite protein (CSP) from the pre-erythrocytic stage. Mosquirix triggers the immune system to defend against the first stages when the Plasmodium falciparum malaria parasite enters the human host's bloodstream through a mosquito bite and infects liver cells. The T-cell epitope of CSP is O-fucosylated in Plasmodium falciparum and Plasmodium vivax, while the RTS,S malaria vaccine produced in yeast is not. The vaccine prevents the parasite from infecting the liver, entering the bloodstream, infecting red blood cells, and leading to disease symptoms. Additionally, due to the vaccine's composition, it protects against the hepatitis B virus; however, it should not be used solely for this purpose.

In July 2015, the European Medicines Agency (EMA) issued a positive regulatory assessment EMEA/H/W/002300/001 of the RTS,S malaria vaccine for 5–17-month-olds, which was updated on July 31, 2020. The EMA updated the scientific information in July 2023. The EMA stated that this malaria vaccine should be used in areas where the Plasmodium falciparum parasite is responsible for causing malaria.

The World Health Organization (WHO) and Malaria Policy Advisory Group (MPAG) recommend the widespread use of the RTS, S/AS01 malaria vaccine among children in sub-Saharan Africa. GSK confirmed that the WHO awarded prequalification to Mosquirix (RTS,S) on September 6, 2022, the first WHO prequalification for a malaria vaccine. The WHO prequalification is a mandatory prerequisite for United Nations agencies, such as UNICEF, to procure the vaccine in partnership with Gavi, the Vaccine Alliance, and eligible countries. The WHO announced the World Malaria Report 2022 on December 8, 2022. In March 2022, a new WHO position paper was published. The WHO posted updated FAQs in July 2023. The WHO's Strategic Advisory Group of Experts (SAGE) updated its recommendations on the malaria vaccine in September 2023. About 1.5 million African children have received the vaccine through a WHO-coordinated pilot program.

In November 2023, Gavi reported data from the evaluation of the pilot introduction of the RTS,S/AS01 malaria vaccine, showing a 13% reduction in mortality from all causes among children eligible for vaccination. The RTS/S vaccine also led to a 22% reduction in hospitalizations for severe clinical malaria. As of June 25, 2025, with Gavi support, RTS,S is expected to be rolled out in 12 African endemic countries through routine immunisation programmes by the end of 2025.

On November 6, 2025, The Lancet Global Health published results from a phase 4 clinical trial, which concluded that over 1 year of follow-up after the third vaccine dose, vaccination with RTS,S/AS01E in real-world settings showed significant reductions in malaria burden. These findings reinforce the continued use of RTS,S/AS01E vaccination in children as an effective public health measure to reduce malaria-related illness and mortality in endemic regions, and highlight its relevance for future malaria control strategies.

GlaxoSmithKline Biologicals S.A. was created in 1987 by scientists working at GSK laboratories - Mosquirix H-W-2300. GSK's commitment to people at risk of malaria is linked. GSK is a science-led global healthcare company with a particular purpose: to help people do more, feel better, and live longer. For further information, please visit GSK.

Mosquirix RTS,S/AS01 Vaccine Availability 2025

As of June 2025, 18 African countries, including Cameroon, Malawi, Kenya, Sierra Leone, and Ghana, have introduced the vaccine into their routine immunization programs. African countries are set to receive 18 million doses over the next two years. The Mosquirix malaria vaccine is not available in the U.S.

Mosquirix RTS,S/AS01 Vaccine Price

On June 25, 2025, Bharat Biotech International Limited and GSK plc announced that Bharat Biotech will reduce the price of RTS,S by more than half, to less than $5, progressively by 2028.

Mosquirix RTS,S/AS01 Vaccine United States

The U.S. Centers for Disease Control and Prevention (CDC) published "Malaria Vaccines: The Way Forward" on October 7, 2021, in collaboration with the Kenya Medical Research Institute. The CDC led the RTS,S/AS01 clinical trial at one site in western Kenya. While the studies are ongoing, sufficient safety and efficacy data have been collected to support a broader recommendation for the RTS,S/AS01 vaccine.

Mosquirix RTS,S/AS01 Vaccine History

GSK developed the RTS,S malaria vaccine over the course of 30 years. The RTS,S vaccine was developed in 1987 as part of a collaboration between GlaxoSmithKline and the Walter Reed Army Institute of Research, which began in 1984.

Mosquirix RTS,S/AS01 Vaccine Indication

On October 6, 2020, the WHO recommended widespread use of the RTS,S/AS01 (RTS,S) malaria vaccine among children in sub-Saharan Africa and other regions with moderate to high P. falciparum malaria transmission. In Europe, Mosquirix is currently indicated for children aged 5 to 17 months and infants aged 6 to 12 weeks at the time of the first vaccination, to help protect against malaria caused by the Plasmodium falciparum parasite. However, Mosquirix is not approved for use in older children, teenagers, or adults.

Mosquirix RTS,S/AS01 Dosage

Mosquirix is administered as an intramuscular injection. The WHO recommends that the RTS,S malaria vaccine be administered in four doses to children aged 5 months and above to reduce the disease burden and malaria incidence. On March 28, 2023, the WHO stated that SAGE recommends flexibility in the immunization schedule and supports reducing the minimum interval between doses 3 and 4 to 6 months to optimize impact.

Mosquirix RTS,S/AS01 Side Effects

The RTS,S/AS01 vaccine safety profile is similar to that of other routine childhood vaccines, except for an increased risk of febrile seizures. At first vaccination, children aged 5–17 months were more likely than controls to have a febrile seizure within seven days after vaccination, especially during the third dose. This effect was transient, and all affected children recovered after seven days. Safety surveillance also suggested a potential increased risk of meningitis and cerebral malaria in this same age group.27 A study in Kenyan children with WHO Stage 1 or 2 HIV disease found that RTS,S/AS01 was well-tolerated in this population and can be safely included in future vaccination programs. The EMA published a Summary of the risk management plan for Mosquirix on July 31, 2020.

RTS, S/AS01E Vaccination with Malaria Chemoprevention

A study published in The Lancet Infectious Diseases in August 2023 confirms that the benefits of combining the RTS, S/AS01E (RTS,S) malaria vaccine with antimalarial drugs (sulphadoxine-pyrimethamine and amodiaquine) reduced clinical malaria episodes, including cases of severe malaria and deaths from malaria in young children by nearly two-thirds (57·7% (53·3 to 61·7) and versus RTS/AS01E-alone being 59·0% (54·7 to 62·8) compared with either RTS, S vaccination or seasonal malaria chemoprevention alone.

Mosquirix RTS, S/AS01 News

November 6, 2025 - Effectiveness of the RTS,S/AS01E malaria vaccine in a real-world setting over 1 year of follow-up after the three-dose primary schedule: an interim analysis of a phase 4 study in Ghana, Kenya, and Malawi was published.

March 7, 2025 - Dr. Aceng commented, "The malaria vaccine introduction in Uganda is a historic step forward in our fight against this deadly disease. With the support of Gavi, UNICEF, and other partners, we ensure that every eligible child has access to this life-saving intervention."

May 6, 2024—The Lancet published a commentary on asymptomatic parasitemia and the efficacy of the RTS,S vaccine. Genotyping results indicated that RTS,S can block infections before the parasite reaches the blood stage. Notably, there was no difference in protective efficacy when comparing head-to-head the RTS,S dosing regimens.

January 9, 2024 - "The selected vaccine, Mosquirix RTS, has been chosen by the country (Cameroon) based on its prequalification, ensuring guaranteed quality, efficacy, and safety for its inclusion in the vaccination programs."

August 22, 2023 - LSHTM Professor Brian Greenwood, MD, a member of the research team, said, "In addition to the study's findings—which by themselves are remarkable—we can say that children who received the RTS,S combination, and also used bednets likely had greater than 90% protection against malaria episodes during the study."

March 28, 2023 - The WHO stated: Introducing the RTS, S malaria vaccine has substantially reduced severe malaria and all-cause mortality among age-eligible children.

April 21, 2022 - The WHO announced more than 1 million children in Ghana, Kenya, and Malawi have received one or more doses of the RTS, S/AS01 (RTS, S) vaccine.

September 9, 2021 - The NEJM journal published an ORIGINAL ARTICLE - Administration of RTS, S/AS01E was noninferior to chemoprevention in preventing uncomplicated malaria. Combining these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone.

January 27, 2021 - GSK, PATH, and Bharat Biotech (BBIL) announced a product transfer agreement for the malaria vaccine, RTS, S/AS01E. Additionally, GSK will retain the production of the adjuvant (AS01E) and supply it to BBIL.

August 23, 2017 - Original Research was published. In conclusion, the RTS, S/AS01E vaccine induces T cells of higher functional heterogeneity and polyfunctionality than previously characterized. Responses detected in memory CD4+ T cell compartments may provide correlates of RTS, S/AS01-induced immunity and duration of protection in future studies of correlates of immunity.

April 23, 2015 - The Lancet published 'The efficacy and safety of RTS, S/AS01 malaria vaccine with or without a booster dose in African infants and children. This trial is registered with ClinicalTrials.gov under the number NCT00866619.

Mosquirix Clinical Trials

The Phase III efficacy and safety trial of RTS, S showed that the vaccine candidate could provide meaningful public health benefits by reducing the burden of malaria.

On August 22, 2023, The Lancet Infectious Diseases published a study that confirms the benefits of combining the RTS,S/AS01E vaccine with antimalarial drugs (sulfadoxine, pyrimethamine, and amodiaquine) to reduce clinical malaria episodes, including cases of severe malaria, and deaths from malaria in young children by nearly two-thirds compared with either RTS,S vaccination or seasonal malaria chemoprevention alone. In April 2024, The Lancet published the results of a study and a related editorial. In the first two years of RTS,S implementation, the three primary doses were effectively delivered in three African countries. No safety issues were observed in the Phase 3 trial, and the introduction of the vaccine was associated with substantial reductions in hospital admissions for severe malaria. On May 6, 2024, The Lancet published results from a phase 3 study that concluded all tested dosing regimens. Improved vaccine efficacy in participants infected during vaccination could suggest new strategies for developing and implementing highly efficacious malaria vaccines.

The Lancet published results from a study in April 2024, among children eligible to have received at least one dose of RTS,S, there was no evidence of an excess of meningitis or cerebral malaria cases in implementation areas compared with comparison areas (hospital admission with meningitis: IRR 0·63 [95% CI 0·22–1·79]; hospital admission with cerebral malaria: IRR 1·03 [95% CI 0·61–1·74]).

The NEJM published the results of a phase 3 clinical study sponsored by the London School of Hygiene and Tropical Medicine on September 9, 2021, which concluded that the administration of RTS, S was noninferior to chemoprevention in preventing uncomplicated malaria. However, combining these interventions resulted in a substantially lower incidence of uncomplicated malaria, severe malaria, and death from malaria than either intervention alone.

Clinical Trial NCT03806465: An Evaluation of the Cluster-randomised Pilot Implementation of RTS, S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa.

Clinical Trial: NCT04661579: The proposed trial design has been developed to answer several questions about nature. The S vaccine efficacy in African adults may be influenced by concurrent and/or past P. falciparum infection and late immunologic hypo-responsiveness. The proposed study design encompasses five groups. Three groups (Groups 1, 2, and 3) will be administered RTS, S/AS01E on a 0-, 1-, and 7-month schedule, with Dose 3 delivered as a 1/5th fractional dose. Two groups (Groups 4 and 5) will receive a comparator vaccine at 0, 1, and 7 months.

Clinical Trial NCT03143218: A double-blind, individual randomized phase 3 trial will be undertaken in 6000 children under the age of five years living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether the malaria vaccine RTS, S/AS01 is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, applicable protection when given together with SMC. The primary trial endpoint will be the incidence of clinical malaria episodes detected through passive case detection. The protective efficacy of the combination compared with the vaccine alone against these outcomes was 59.6% (95% CI, 54.7-64.0), 70.6% (95% CI, 42.3-85.0), and 75.3% (95% CI, 12.5-93.0), respectively.

0 min read

Manufacturer:

GSK

Reviewer:

Mosquirix RTSS/AS01e Malaria Vaccine

Vaccine:

VIS:

Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules

Availability:

Malaria endemic countries under investigational protocol, WHO Prequalification

Generic:

RTS,S/AS01

Clinical Trial:

https://www.malariavaccine.org/files/content/page/files/RTSS%20vaccine%20candidate%20Factsheet_FINAL.pdf

Drug Class:

Recombinant vaccine that contains an adjuvant

Clinical Trial Phase I:

Clinical Trial Phase II:

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Schedules

Clinical Trial Phase III:

An Extension to Study MALARIA-055 PRI to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals'

Clinical Trial Phase IV:

Effectiveness of the RTS,S/AS01E malaria vaccine in a real-world setting over 1 year of follow-up after the three-dose primary s

Lab Test:

CDC

Condition:

Malaria

Availability Link:

WHO

Last Reviewed:

Wednesday, November 12, 2025 - 07:55

Brand:

Mosquirix

Abbreviation:

H-W-2300

Status:

Authorized

Manufacturer Country ID:

FDA First In Class:

Yes

Kosher:

Yes

Side Effects:

Ingredients:

Countries:

Rate Vaccine:

nh1mZnX5

Location tags:

Africa

Menveo Meningococcal Vaccine

Menveo Vaccine Clinical Trials, Dosage, Efficacy

GSK's Menveo helps protect appropriate adolescent patients with a primary and booster dose of MENVEO. It consists of two portions: 10 µg of lyophilized meningococcal serogroup A capsular polysaccharide conjugated to CRM197 and 5 μg each of capsular polysaccharide of serogroup C, W, and Y conjugated to CRM197 in 0.5 mL of phosphate-buffered saline, which is used to reconstitute the lyophilized MenA component. Menveo does not prevent N. meningitidis serogroup B infections. The immunogenicity of MENVEO was evaluated 28 days after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 28 days after a dose of either MENVEO or Menactra.

The European Commission approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135, and Y conjugate vaccine, MenACWY vaccine) in November 2024 to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W, and Y.

This single-vial presentation is now licensed for active immunization of children from 2 years to adolescents and adults. It offers healthcare providers an option that does not require reconstitution before use.

The U.S. Prescribing Information is available at this weblink. GSK Medical Information: 1-877-GSK-MI4U (1-877-475-6448). The U.S. CDC Advisory Committee on Immunization Practices (ACIP) vaccine committee reviewed the Menveo One-Vial Presentation on October 20, 2022, led by Sam Crowe, Ph.D., MPH Work Group Lead.

Menveo Indication

Menveo is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The U.S. CDC recommends MenACWY vaccination for children who are between 2 months and 10 years old if they:

Have a rare type of immune disorder called complement component deficiency
Are taking a type of medicine called a complement inhibitor (for example, Soliris® or Ultomiris®)
Have a damaged spleen or sickle cell disease, or their spleen has been removed
Have HIV
Are traveling to or residing in countries in which serogroup A, C, W, or Y meningococcal disease is common
Are part of a population identified to be at increased risk because of a serogroup A, C, W, or Y meningococcal disease outbreak

All 11 to 12-year-olds should get a MenACWY vaccine, with a booster shot at 16 years old.

Menveo Dosage

MENVEO is approved for use in individuals 2 through 55 years and administered as an intramuscular injection. In children initiating vaccination at 2 months of age, Menveo is to be administered as a 4-dose series at 2, 4, 6, and 12 months of age.

Menveo Adverse Reactions

Common solicited adverse reactions among children initiating vaccination at 2 months of age and receiving the 4-dose series were tenderness and erythema at the injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea at 7 months through 23 months of age and receiving the 2-dose series were tenderness and erythema at the injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age who received Menveo were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults aged 11 through 55 years who received a single dose of Menveo were pain at the injection site, headache, myalgia, malaise, and nausea. Across all age groups, some events were severe. Similar rates of solicited adverse reactions among adolescents and adults were observed following a single booster dose.

Menveo Vaccine News

November 27, 2024—Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: "As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunization and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis and will persist in our efficacy in preventing devastating disease among at-risk populations in the European Union."

October 17, 2022 - GSK announced that the US FDA had approved a new presentation of Menveo for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready-to-use single vial, giving healthcare providers a more convenient option.

August 18, 2022—Florida Health departments offer meningococcal vaccines for free. The state has been experiencing an outbreak this year, recording over 50 cases. February 9, 2022 - GSK reported that during 2021, Menveo sales were up 3% AER 9% CER to £272 million, primarily driven by 2020 cohort catch-up vaccinations and 2021 higher demand, as well as increased market share in the U.S.

Menveo Clinical Trials

GSK's Menveo has been involved in many clinical trials.

0 min read

Manufacturer:

GSK

Reviewer:

Menveo Meningococcal Vaccine

Vaccine:

VIS:

Drug Class:

Vaccine

Find Price:

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY

Clinical Trial Phase II:

Clinical Trial Phase III:

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vacci

Clinical Trial Phase IV:

Understanding the Immune Response to Two Different Meningitis Vaccines

Lab Test:

FDA

Condition:

Meningococcal

Last Reviewed:

Wednesday, November 27, 2024 - 06:45

Brand:

Menveo

Status:

Manufacturer Country ID:

Side Effects:

Adverse Reactions

Ingredients:

Description

Countries:

U.S.

Rate Vaccine:

uwDYi1j5

Menactra Meningococcal Vaccine

The U.S. FDA-approved Menactra® contains N meningitidis serogroup 8 A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid 9 protein. N meningitidis A, C, Y, and W-135 strains are cultured on Mueller Hinton agar and ten grown in Watson Scherp media containing casamino acid.

Vaccines can help prevent meningococcal disease, which is any type of illness caused by Neisseria meningitidis bacteria., says the U.S. CDC.

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Sanofi Pasteur Inc. STN/BL: 125089

Menactra Indication

Menactra® is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra vaccine is approved for use in individuals nine months through 55. Menactra vaccine does not prevent N meningitidis serogroup B disease.

Menactra is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid-, or CRM197-containing vaccine or to any component of the vaccine.

Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS after receiving Menactra. In addition, GBS has been reported in temporal relationships following the administration of Menactra. Therefore, giving Menactra should be based on carefully considering the potential benefits and risks.

Menactra Dosage

The U.S. CDC's ACIP recommends that 16-year-old adolescents receive the 2nd dose of MenACWY. Primary Vaccination: Children 9 months through 23 months of age: Two doses, three months apart. Individuals 2 through 55 years of age: A single dose. Booster Vaccination: A single booster dose may be given to individuals 15 through 55 at continued risk for meningococcal disease if at least four years have elapsed since the last dose.

Meningococcal News

August 18, 2022 - Florida has recorded 50 cases of meningococcal disease so far this year. The case fatality in Florida is 25%, and 1 in 4 people diagnosed have died from this disease.

April 27, 2018 - U.S. FDA Supplemental Approval letter.

Menactra Clinical Trials

Sanofi's Menactra Meningococcal Vaccine has been involved in over 40 clinical trials to determine safety and immunogenicity.

0 min read

Manufacturer:

Sanofi Pasteur

Reviewer:

Menactra Meningococcal Vaccine

Vaccine:

VIS:

Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

Availability:

U.S.

Generic:

Meningococcal Vaccine

Drug Class:

Vaccine

Clinical Trial Phase I:

Clinical Trial Phase II:

Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

Clinical Trial Phase III:

Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Clinical Trial Phase IV:

Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

Condition:

Meningococcal

Availability Link:

U.S. FDA

Last Reviewed:

Friday, May 26, 2023 - 09:50

Brand:

Menactra

Status:

Ridgeback Biotherapeutics

Manufacturer Country ID:

Side Effects:

Ingredients:

Countries:

Rate Vaccine:

nxozw6HX

Ebanga Ebola Antibody

Ebanga™ Ebola Monoclonal Antibody Clinical Trials, Dosage, Indication, Side Effects

Ebanga™ (mAb114, Ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody (mAb) indicated for the treatment of infection in adults and children. Ebanga (mAb114) is available in a lyophilized form and is a single monoclonal antibody (mAb) that binds to the core receptor binding domain of the Zaire ebolavirus surface protein, preventing the virus from infecting human cells. It was isolated from the blood of a survivor of the 1995 Ebola virus disease (EVD) outbreak in the Democratic Republic of Congo (DRC). mAbs are proteins produced in a lab or other manufacturing facility that act like natural antibodies to stop a germ, such as a virus, from replicating after it has infected a person. These particular mAb binds to a portion of the Ebola virus's surface called the glycoprotein, which prevents the virus from entering a person's cells. This area of the Ebola glycoprotein, the receptor binding domain (RBD), was previously thought to be unreachable by antibodies because it is well-hidden by other parts of the virus and only becomes exposed after it enters the cell.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and researchers at Dartmouth College studied how Ebang neutralizes the EBOV and determined that it binds to the core of the Ebola glycoprotein, blocking its interaction with a receptor on human cells. The U.S. Vaccine Research Center developed Ebanga (mAb114) with support from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Ebanga was granted an FDA Orphan Drug and Breakthrough Therapy designation. The U.S. Food and Drug Administration (FDA) authorized Ebanga for intravenous injections on December 21, 2020.

On August 19, 2022, the World Health Organization (WHO) Guideline Development Group (GDG) made a Strong Recommendation for treatment with mAb114 for patients with real-time polymerase chain reaction (RT-PCR) confirmed EVD and for neonates of unconfirmed EVD status, seven days or younger, born to mothers with confirmed EVD. This new WHO living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures.

As of September 14, 2025, treatment courses of Mab114 have been dispatched to treatment centers in Bulape, DRC.

Emergent BioSolutions agreed with Ridgeback Biotherapeutics to expand the availability of Ebanga on July 7, 2022. Emergent is responsible for the manufacturing, sale, and distribution of Ebanga in the USA and Canada, and Ridgeback Bio serves as the global access partner for Ebanga. Ridgeback Biotherapeutics L.P. is located in Miami, FL. Ridgeback obtained a license for mAb114 from the U.S. NIH in 2018. DrugBank: DB16385; UNII: TG8IQ19NG2.

Ebanga Indication

Ebanga is indicated for treating infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, tissues of infected people or wild animals, and surfaces and materials, such as bedding and clothing, contaminated with these fluids. The efficacy of Ebanga has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as the emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Ebanga.

Ebanga Dosage

Ebanga is administered by IV infusion at doses of 5, 25, and 50 mg. Ebanga is available in a lyophilized form. For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.

Ebanga Side Effects and Interactions

Hypersensitivity reactions, including infusion-associated events, have been reported with Ebanga. These may include acute, life-threatening responses during and after the infusion. Discontinue the administration of EBANGA immediately and administer appropriate emergency care. No studies have been conducted on vaccine interactions. Ebanga may reduce the efficacy of the live vaccine. The interval between the administration of Ebanga therapy and live vaccination should be in accordance with current vaccination guidelines.

BARADA Agreements

BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). On September 12, 2024, Emergent announced that it had been awarded a contract modification valued at $41.9 million for drug substance engineering and scale-up process validation, as well as long-term stability and commercial readiness, to support its ongoing scale-up program for Ebanga. On July 31, 2023, Emergent announced that BARDA had awarded it a 10-year contract, valued at up to a maximum of $704 million, under contract number 75A50123C00037, for the advanced development, manufacturing scale-up, and procurement of Ebanga™. On January 13, 2025, the company executed a contract modification for the second option period, valued at approximately $16.7 million, for drug product process and analytical testing validation, as well as long-term stability, for Ebanga™.

Ebanga (mAb114) News

September 14, 2025 - The WHO reported that treatment courses of the monoclonal antibody therapy (Mab114) drug have also been sent to treatment centers in Bulape, an area in the DRC, for clinical care during the 17th Ebola outbreak.

January 13, 2025 - Simon Lowry, M.D., chief medical officer, head of research and development, Emergent, commented, "Ebola is a devastating infectious illness with limited treatment options. This important work reinforces Emergent's leadership in developing solutions to address priority public health threats."

September 12, 2024 - Paul Williams, senior vice president of products business, Emergent, stated, "We look forward to progressing the program to supply treatment courses to enable preparedness against the Ebola virus. This important work demonstrates our leadership position in providing critical medical countermeasures."

July 31, 2023: Dr. Kelly Warfield, senior vice president of science and development at Emergent, stated in a press release, "The Ebola virus can emerge unexpectedly, posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, underscoring the importance of preparedness efforts against this public health threat."

March 8, 2023: The journal Frontiers published an article titled "Ebanga™: The most recent FDA-approved drug for treating Ebola."

September 30, 2022 - AllAfrica published Ebola - What Are the Symptoms, How Does It Spread, and Where Did It Come From?

August 19, 2022: The WHO published its first guideline for Ebola virus disease therapeutics, with strong new recommendations for monoclonal antibodies. The WHO calls on the global community to increase access to these medicines.

July 7, 2022 - Emergent BioSolutions Inc. confirmed an agreement with Ridgeback Biotherapeutics to expand the availability of Ebanga.

April 1, 2021 - The NEJM Journal reported that during the 2018–2020 Ebola virus disease (EVD) outbreak in North Kivu province in the Democratic Republic of Congo, EVD was diagnosed in a patient who had received the recombinant vesicular stomatitis virus-based vaccine expressing a ZEBOV glycoprotein (rVSV-ZEBOV) (Merck). His treatment included an Ebola virus (EBOV) -specific monoclonal antibody (mAb114), and he recovered within 14 days. However, six months later, he presented again with severe EVD-like illness and EBOV viremia and died. Epidemiologic and genomic investigations showed that the patient relapsed into acute EVD, leading to a transmission chain resulting in 91 cases across six health zones over four months.

February 2, 2021—The antibody mAb114, or ansuvimab, is marketed as Ebanga by Ridgeback Therapeutics L.P. of Miami. The company licensed the antibody and manufacturing processes from NIAIOverhan. In 2018, the Frederick National Laboratory's Vaccine Clinical Materials Program manufactured 10,000 drug product vials for use in clinical trials in the Democratic Republic of the Congo.

December 22, 2020 - Ridgeback Biotherapeutics L.P. announced today that the U.S. Food and Drug Administration approved Ebanga to treat Ebola. Ebanga is now approved to treat infections caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are RT-PCR positive for Zaire ebolavirus infection. The efforts of the Pamoja Tulinde Maisha (PALM ["Together Save Lives" in the Kiswahili language]) study team conclusively demonstrated Ebanga's safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history. The PALM study team's efforts represent a landmark achievement in developing medical countermeasures for emerging infectious diseases.

December 21, 2020 - The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment of Ebolavirus infection in adults and children. Ebanga blocks the binding of the virus to the cell receptor, preventing its entry into the cell.

August 28, 2020—Ridgeback Biotherapeutics LP. announced the implementation of an expanded access protocol to ensure rapid access to its promising Ebola treatment, ansuvimab, in the Democratic Republic of the Congo (DRC). The Institut National de Recherche Biomédicale of the DRC is conducting an open-label, expanded-access clinical trial, initiated earlier this month. Ridgeback is providing study drug and operational support for this trial.

September 6, 2019: Ridgeback Biotherapeutics L.P. announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation.

August 13, 2019: The first-ever multi-drug randomized controlled trial to evaluate the safety and efficacy of Ebola Zaire therapeutic medications reported two experimental products that would continue to be studied. The investigational agents in the Pamoja Tulinde Maisha study were ZMapp, remdesivir, mAb114, and REGN-EB3. Additionally, this DSMD said, 'all future study participants should be randomized to receive either the REGN-EB3 or mAb114 medications.'

December 13, 2018 - Ridgeback Biotherapeutics L.P. announced that it has entered into a patent license agreement with the NIH for intellectual property related to the mAbs mAb114, an experimental treatment for Ebola.

Ebanga (mAb114) Antibody Clinical Trials

The Pamoja Tulinde Maisha (PALM [together save lives]) study was a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114, and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018, in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. EBANGA lowered the risk of dying from the infection.

0 min read

Manufacturer:

Reviewer:

Vaccine:

Ebanga Ebola Antibody

VIS: