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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: 
Robert Carlson, MD
Vaccine: 
Mosquirix RTSS/AS01e Malaria Vaccine
VIS: 
PDF
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: 
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules
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: 
UK
FDA First In Class: 
Yes
Kosher: 
Yes
Side Effects: 
Side Effects
Ingredients: 
EMA
Countries: 
Europe
Ghana
Malawi
Burkina Faso
Mali
WHO
Nigeria
Kenya
India
Cameroon
Liberia
Niger
Rate Vaccine: 
nh1mZnX5
Location tags: 
Africa

Menactra Meningococcal Vaccine

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: 
Robert Carlson, MD
Vaccine: 
Menactra Meningococcal Vaccine
VIS: 
PDF
Availability: 
U.S.
Generic: 
Meningococcal Vaccine
Drug Class: 
Vaccine
Clinical Trial Phase I: 
Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years
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: 
Approved
Manufacturer Country ID: 
FR
Side Effects: 
Contraindications
Ingredients: 
FDA
Countries: 
USA
India
Rate Vaccine: 
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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: 
Ridgeback Biotherapeutics
Reviewer: 
Robert Carlson, MD
Vaccine: 
Ebanga Ebola Antibody
VIS: 
PDF
Availability: 
USA, Africa
Generic: 
Ansuvimab-zykl
Clinical Trial: 
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-ebanga
Drug Class: 
Monoclonal antibody
Clinical Trial Phase I: 
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy
Lab Test: 
U.S. CDC
Condition: 
Zaire Ebolavirus
Availability Link: 
Emergent BioSolutions
Last Reviewed: 
Monday, September 15, 2025 - 04:20
Brand: 
Ebanga
Abbreviation: 
mAb114
ChEMBL ID: 
2375952-29-5
Accession Number: 
DB16385
Status: 
Authorized
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
Side Effects: 
FDA PI
Ingredients: 
INgredients
Countries: 
USA
Africa
UNII: 
TG8IQ19NG2
Rate Vaccine: 
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Ixiaro Japanese Encephalitis Vaccine

IXIARO® JESPECT® Japanese Encephalitis Vaccine Clinical Trials, Dosage, Indication, Side Effects

Valneva SE's IXIARO® (JESPECT® in Australia and New Zealand) is an inactivated, adsorbed Vero cell culture-derived vaccine targeting the Japanese encephalitis virus (JEV). It is prepared by propagating the JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified, and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The partially purified virus is processed and fractionated through sucrose density gradient centrifugation. Each fraction is analyzed for the presence of the virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by formaldehyde treatment. IXIARO's final preparation is adjusted to a specified protein concentration and formulated by adding aluminum hydroxide.

The IXIARO JEV was developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. In 2018, the U.S. Food and Drug Administration (FDA) issued STN: BL 125280, which included a statistical review, Clinical Review, and toxicology review. An approval letter was issued on October 4, 2018. 

The U.S. Department of Defense (DoD) has relied on IXIARO since 2010 to help protect personnel deployed to JE-endemic areas for whom JE vaccination is recommended. Under a new one-year contract announced on September 25, 2023, the DoD will purchase a minimum of $32 million in IXIARO® vaccines and may buy additional doses over the next 12 months. Vaccine deliveries will commence in 2023. On January 30, 2025, Valneva announced a new one-year contract under which the DoD will purchase a minimum of $32.8 million worth of IXIARO and may purchase additional doses over the following 12 months.

A study estimated that between 2000 and 2015, 307,774 JE cases (95% CI: 167,442–509,583) were averted globally due to vaccination. The UK Health Security Agency published new guidance on JE vaccination in the 'Green Book' (Chapter 20) in February 2024. On September 5, 2024, the U.S. CDC published the Japanese Encephalitis Vaccine Evidence-to-Recommendations Framework, and in April 2025, it updated the JE Yellow Book 2026.

France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company focused on developing vaccines for diseases with significant unmet needs. For more information, visit www.valneva.com. Valneva USA, Inc. is located at 910 Clopper Road, Suite 160S, Gaithersburg, MD 20878, USA. 

IXIARO Vaccine Availability 2025

As of 2025, IXIARO is the only Japanese encephalitis vaccine approved by the U.S. FDA, which is commercially available at various travel vaccine retailers. IXIARO/JESPECT is licensed for adults in the United States, Australia, New Zealand, Europe, Canada, Germany, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO®/JESPECT® is indicated for use by adults. In Germany, CSL Seqirus will distribute IXIARO®.

Visit PreventJE.com, a website for travel health professionals and their patients focusing on the risk and prevention of Japanese encephalitis in travelers to Asia. In Australia, information on eligibility for the free JE vaccine is available on the NSW Health website.

IXIARO Vaccine Approvals

In March 2009, the U.S. Food and Drug Administration (FDA) approved JE-VC for adults aged 17 years and older. In June 2009, the CDC's Advisory Committee on Immunization Practices (ACIP) approved recommendations for the use of JE-VC in adults. In September 2010, the FDA approved a JE-VC booster dose for adults. In May 2013, FDA approval for JE-VC was extended to include children aged two months through 16 years. ACIP recommendations for the pediatric use of JE-VC were approved in June 2013. In April 2018, the FDA approved a booster dose for the pediatric age group. On March 8, 2020, Valneva announced that the FDA approved an extension of the shelf life of IXIARO from 24 months to 36 months.

IXIARO Indication

IXIARO is indicated for active immunization to prevent disease caused by the JEV, the leading cause of vaccine-preventable encephalitis, and is approved by the U.S. CDC for use in individuals two months of age and older. The CDC says travelers to areas at risk for Japanese encephalitis should discuss the need for vaccination with their healthcare provider. JE is a deadly infectious disease occurring throughout most of Asia and parts of the western Pacific, spread by mosquitoes, pigs, and sheep. JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage.

IXIARO Side Effects

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Therefore, severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO®, any other Japanese encephalitis vaccine, or any component of IXIARO®, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to the administration of IXIARO®. Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered. The most common ( > 10%) adverse reactions were fever, irritability, diarrhea, and injection site redness in infants two months to < 1 year of age; fever in children 1 to < 12 years of age; pain and tenderness in adolescents 12 to < 18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

IXIARO Dosage

IXIARO is administered by intramuscular injection and is approved for use in individuals 2 months of age and older. In 2019, the U.S. CDC's ACIP committee strengthened its language on booster doses, stating that they should be given at least 1 year after the primary series if the person has ongoing or re-exposure to the JE virus.   

Primary Series: Children 2 months to <3 Years of age: Primary immunization with IXIARO consists of two (2) 0.25 mL doses, administered 28 days apart; Individuals 3 years of age and older: Primary immunization with IXIARO consists of two (2) 0.5 mL doses, administered 28 days apart; Complete the primary immunization series at least one week before potential exposure to JEV.

Booster Dose: Individuals 17 years of age and older: If the primary series of two doses was completed more than one year previously, a booster dose might be given if ongoing exposure or re-exposure to JEV is expected; Infants, children, and adolescents two months to <17 years of age: The safety and immunogenicity of a booster dose have not been evaluated.

Immunocompromised individuals may have a diminished immune response to IXIARO.

U.S. CDC Japanese Encephalitis Vaccine Recommendations

The U.S. CDC developed Japanese Encephalitis vaccine recommendations using an explicit evidence-based method based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Japanese Encephalitis Outbreaks

The World Health Organization (WHO) states that JE outbreaks intensify during the rainy (monsoon) season in Asia (India, Nepal) and the Pacific (Australia), when vector populations increase.

IXIARO Vaccine Sales

In the first half of 2025, IXIARO® /JESPECT® sales increased by 30.6% to €54.7 million compared to €41.9 million in the first half of 2024. Sales to both travelers and the DoD grew in double digits compared to the first half of 2024, when IXIARO® supply constraints impacted sales.

In 2024, IXIARO/JESPECT sales increased by 28% to €94.1 million, demonstrating double-digit growth among travelers and the U.S. Department of Defense compared to 2023. Valneva has been supplying additional doses of IXIARO® to the U.S. DoD under the current contract, signed in September 2023.

IXIARO Vaccine News

August 12, 2025 - Peter Bühler, Valneva's Chief Financial Officer, commented, "We also substantially reduced our spending and successfully leveraged our ATM program to welcome two new leading healthcare investors among our main shareholders, strengthening our financial position ahead of this important clinical catalyst."

January 30, 2025 - Dipal Patel, Chief Commercial Officer of Valneva, commented, "We are honored to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."

November 7, 2024 - Valneva anticipates receiving new vaccine orders in 2025.

October 31, 2024 - Victoria's Minister for Health, Mary-Anne Thomas, stated, "Following expert advice from the Chief Health Officer, we're expanding this important program to ensure more Victorians can access the free JEV vaccine and protect themselves and their loved ones this summer."

May 15, 2024 - The U.S. CDC published Japanese Encephalitis Vaccine Information for Healthcare Providers.

September 25, 2023 - Dipal Patel, Chief Commercial Officer of Valneva SE, commented, "We are excited to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."

September 21, 2023 - Valneva SE confirmed it distributes IXIARO® directly to the U.S. DoD.

July 11, 2022 - A non-peer-reviewed study: Safety and immunogenicity following co-administration of Yellow fever vaccine with Tickborne encephalitis or Japanese encephalitis vaccines concluded: Inactivated TBEV or JEV vaccines can be co-administered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses.

September 3, 2021 - Valneva SE announced that the U.S. Department of Defense had exercised the first option of the contract signed in September 2020 to purchase a further supply of its Japanese encephalitis vaccine, IXIARO®.

July 19, 2019 - The CDC's Advisory Committee on Immunization Practices (ACIP) Recommendations for Japanese Encephalitis Vaccine were updated.

June 5, 2019: The European Medicines Agency approved the extension of the shelf life of the Japanese encephalitis vaccine IXIARO from 24 months to 36 months.

March 1, 2019 – At its meeting on February 27, 2019, the U.S. CDC's ACIP voted unanimously to expand the JEV vaccination recommendations. 

Ixiaro Clinical Trials

Ixiaro, the Japanese Encephalitis vaccine, has been involved in over 60 clinical trials.  

0 min read
Manufacturer: 
Valneva
Reviewer: 
Robert Carlson, MD
Vaccine: 
Ixiaro Japanese Encephalitis Vaccine
VIS: 
PDF
Availability: 
Various countries including the U.S.
Generic: 
JESPECT
Clinical Trial: 
https://clinicaltrials.gov/search/intervention=Ixiaro
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination
Clinical Trial Phase II: 
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Clinical Trial Phase III: 
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
Clinical Trial Phase IV: 
This is a Study to Assess the Safety and Immunogenicity of Ixiaro® (IC51) in an Elderly Population
Lab Test: 
CDC
Condition: 
Japanese Encephalitis
Availability Link: 
Valneva
Last Reviewed: 
Thursday, December 18, 2025 - 10:05
Brand: 
Ixiaro
CPT Code: 
90738
Accession Number: 
DB10769
Status: 
Approved
Manufacturer Country ID: 
FR
FDA First In Class: 
Yes
Side Effects: 
Warnings and Precautions
Ingredients: 
Description
Countries: 
U.S.
Austria
EU
Australia
UK
New Zealand
Canada
Japan
Germany
UNII: 
DZ854I04ZE
Cell Line Production: 
Vero Cells
Rate Vaccine: 
Pb2wtsIN
Location tags: 
United States of America
Australia
India
Germany
Japan
New Zealand
Nepal
South Korea
Taiwan
Austin
China

INO-A002 Zika Vaccine

INO-A002 Zika Vaccine Description 2022

INO-A002 is a DNA-encoded monoclonal antibody (dMAb™) technology candidate.

INO-A002 Indication

INO-A002 is indicated to prevent or treat the Zika virus infection.

INO-A002 Dosage

The vaccine will be delivered as an intramuscular (IM) injection followed by electroporation with the CELLECTRA® 2000 device. 

When delivered directly into the body, the genetic codes provided by the synthetic dMAbs instruct the body's cells to become the factory that manufactures the therapeutic antibody products.

INO-A002 News 2019 - 2022

February 20, 2019 - Inovio Pharmaceuticals, Inc. in collaboration with The Wistar Institute and the University of Pennsylvania announced that the first subject was dosed as part of the first-ever human study of Inovio's DNA-encoded monoclonal antibody (dMAb™) technology.

INO-A002 Clinical Trial

INO-A002 is currently in a Phase 1 clinical trial.

The trial is led by Pablo Tebas, M.D., Professor of Medicine at the Hospital of the University of Pennsylvania.

0 min read
Manufacturer: 
Inovio
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
INO-A002 Zika Vaccine
Generic: 
INO-A002
Drug Class: 
DNA-encoded monoclonal antibody vaccine
Clinical Trial Phase I: 
A Study of INO-A002 in Healthy Dengue Virus-naive Adults
Condition: 
Zika
Last Reviewed: 
Monday, December 5, 2022 - 05:25
Status: 
Candidate
Manufacturer Country ID: 
US

Infanrix Vaccine

Infanrix® Pediarix™ Combination Vaccine

Infanrix® (STN: BL 103647) is a vaccine combination indicated for active immunization against diphtheria, tetanus, and pertussis, approved in 1997. Infanrix active ingredients are non-infectious substances from tetanus, diphtheria bacteria, and purified proteins of pertussis bacteria. Pediarix™ [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 2002.

In Europe, Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib). And in New Zealand, INFANRIX-IPV Combined diphtheria-tetanus-acellular pertussis (DTPa) and enhanced inactivated polio suspension for injection.

Infanrix Vaccine Indication

Infanrix is a vaccine indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children six weeks to 7 years of age (before the seventh birthday).

Infanrix Vaccine Dosage

Infanrix is approved for intramuscular administration in infants and children six weeks to 7 years of age (before the seventh birthday) as a 5-dose series. A primary immunization course of 3 doses is administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks). The first dose may be given as early as six weeks of age. Followed by two booster doses, administered at 15 to 20 months and 4 to 6 years of age. Preferred administration site: Anterolateral aspect of the thigh for most infants younger than 12 months. Deltoid muscle of the upper arm for most children 12 months of age to 7 years of age. Each 0.5 mL dose contains 30 IU (25 Lf U) of diphtheria toxoid.

Infanrix Vaccine News

February 21, 2022 - The UK Health Agency published the 2022 routine immunization schedule. This publication included immunization programs as well as additional vaccines for individuals with underlying medical conditions.

February 9, 2022 - GSK reported sales of DTPa-containing vaccines (Infanrix, Pediarix, and Boostrix) decreased 4% AER but grew 1% CER. Infanrix/Pediarix sales decreased 14% AER and 9% CER to £543 million, reflecting lower tender volume in Europe and internationally and a change in recommendation for the dosing schedule in Germany, partly offset by increased demand in the US. Boostrix sales grew 9% AER and 14% CER to £521 million, primarily driven by demand recovery and tender volumes in International, as well as higher demand and share in the US.

October 31, 2019 - GSK Korea announced its newly launched Infanrix IPV-Hib, a quintuplet vaccine that covers diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b (Hib). The company hopes that by adding efficiency to the excellence of the existing Infanrix brand, it can become a vaccine that leads to disease prevention for infants and toddlers, said Professor Lee Jin of the Department of Pediatrics at Hanil Hospital.

Infanrix Vaccine Clinical Trials

Infanrix has been tested in over 140 clinical trials. They can be found at this link.

0 min read
Manufacturer: 
GSK
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Infanrix Vaccine
VIS: 
PDF
Generic: 
Dtap
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase II: 
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Clinical Trial Phase III: 
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Clinical Trial Phase IV: 
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With B
Condition: 
Childhood Diseases
Last Reviewed: 
Friday, July 28, 2023 - 06:10
Brand: 
Infanrix
CPT Code: 
90700
Accession Number: 
DB10992
Status: 
Approved
Manufacturer Country ID: 
UK
Side Effects: 
Adverse Reactions
Ingredients: 
Description
Countries: 
U.S.
UNII: 
I05O535NV6
Rate Vaccine: 
h7gxqQIP

West Nile Vaccine Candidate HydroVax-001

West Nile Virus Vaccine Candidate HydroVax-001

HydroVax-001 is a West Nile Virus (NV) vaccine candidate with a hydrogen peroxide inactivated whole virion (WNV-Kunjin strain) adjuvanted with aluminum hydroxide. HydroVax-001 was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. HydroVax-001 was created with a novel, hydrogen peroxide-based process that renders the virus inactive while maintaining key immune-system triggering surface structures. The OHSU research team, led by senior scientist Mark Slifka, Ph.D., created the investigational vaccine. The virus used to make the vaccine is inactivated and cannot cause WNV infection. Because it is inactivated, the experimental vaccine likely could be used in a diverse population, including immunologically vulnerable groups, such as the elderly.

The scientists were funded with a $7.2 million grant awarded in 2009 from the NIAID, part of the US National Institutes of Health. “Since first appearing in the United States in 1999, West Nile Virus has emerged as an important health threat in this country. NIAID is committed to research efforts to advance a preventive vaccine that could protect people against West Nile Virus infection,” said former NIAID Director Anthony S. Fauci, M.D.

The NIAID supports research on various vaccine approaches that could potentially lead to a safe and effective preventive vaccine for the West Nile virus. These approaches include cocktails of individual WNV proteins and chimeric vaccines, which combine genes from more than one virus into a single vaccine. A third approach involves DNA vaccines, in which DNA that codes for a particular virus protein is combined with bacterial DNA, and the combined product is injected directly into the skin of the person or animal being vaccinated.

HydroVax-001 Vaccine Indication

HydroVax-001 is indicated to prevent the WNV but is not U.S. FDA-approved. The vaccine candidate is tested in a Phase 1 clinical trial at Duke University in Durham, N.C., one of NIAID’s Vaccine and Treatment Evaluation Units.

HydroVax-001 Vaccine Dosage

The HydroVax-001 vaccine is currently administered intramuscularly in a two-dose series. No pediatric vaccine efficacy indication has been disclosed. 

HydroVax-001 Vaccine News

September 30, 2019 - Oregon Health & Science University spinoff Najít Technologies, Inc., of Beaverton, Oregon, will test a yellow fever version of the HydroVax vaccine platform licensed from OHSU. A $3.1-million grant from the National Institutes of Health to Najít will enable Duke University to lead the Phase 1 human clinical trial and OHSU to study how trial participants’ immune systems respond to the yellow fever vaccine. The trial is expected to start in 2020 and take up to a year to complete.

January 18, 2019 - The HydroVax-001 WNV vaccine was modestly immunogenic and well-tolerated at all doses. HydroVax-001 was safe and well-tolerated, as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT50 but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added compliment, PRNT50 seroconversion rates increased to 50%, and WNV-specific ELISA observed 75% seroconversion.

December 3, 2016 - Europe PMC published: Pre-clinical development of a hydrogen peroxide-inactivated West Nile virus vaccine.

July 9, 2015 - A new U.S. NIH-funded investigational vaccine to protect against West Nile Virus, discovered and developed by OHSU researchers, is entering Phase I clinical trials. The OHSU team, led by Mark Slifka, Ph.D., created the test vaccine, called HydroVax-001, with a novel hydrogen peroxide-based approach that renders the virus inactive while maintaining its integrity; an intact surface structure permits the triggering of an immune response to cells infected with the virus. This preparation will allow the test vaccine to be administered to a diverse population, including those most vulnerable to the virus, such as the elderly and immune-compromised individuals.

HydroVax-001 Vaccine Candidate Clinical Trial

Clinical Trial NCT02337868: Phase 1 Trial of Inactivated West Nile Virus Vaccine.

Phase 1 study results in July 2019: HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT50 but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added compliment, PRNT50 seroconversion rates increased to 50%, and 75% seroconversion was observed by WNV-specific ELISA.

July 6, 2015 - A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland discovered and developed the experimental vaccine. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a Phase 1 clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).

0 min read
Manufacturer: 
Oregon National Primate Research Center at Oregon Health & Science University
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
West Nile Vaccine Candidate HydroVax-001
Clinical Trial: 
https://www.nih.gov/news-events/news-releases/nih-funded-vaccine-west-nile-virus-enters-human-clinical-trials
Drug Class: 
Inactivated Vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
Phase 1 Trial of Inactivated West Nile Virus Vaccine
Condition: 
West Nile Virus
Last Reviewed: 
Saturday, July 27, 2024 - 09:10
Brand: 
HydroVax-001
Status: 
Candidate
Manufacturer Country ID: 
US

Heplisav-B Hepatitis B Vaccine

Heplisav-B® Vaccine Clinical Trials, Dosage, Indication, Side Effects

The Heplisav-B® two-dose vaccine enhances the immune response by combining hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) and nine agonists. Dynavax's HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is an adult hepatitis B vaccine indicated to prevent infection caused by all known subtypes of the hepatitis B virus in adults 18 years and older. HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and Great Britain.

TLRs are expressed on dendritic cells and other innate immune cells and are among the most important receptors for eliciting a response to the presence of invading pathogens. Humans have ten types of TLRs that are similar in structure but recognize different viruses or bacteria. Thus, activating specific TLRs can stimulate and control particular types of innate immune responses that can be harnessed to enhance adaptive responses and potentially improve vaccines and cancer-killing activities. Research at Dynavax has identified proprietary, synthetic oligonucleotides (short segments of DNA) that selectively and optimally activate these receptors.

In 2017, HEPLISAV B became a U.S. Food and Drug Administration (FDA) (BLA 125428) and European Commission-approved hepatitis B vaccine for adults with a two-dose regimen completed in one month. On February 28, 2023, the United Kingdom Medicines and Healthcare products Regulatory Agency granted Marketing Authorization in Great Britain to Dynavax GmbH for HEPLISAV B, indicated for active immunization against HBV caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. 

Dynavax announced on May 14, 2024, a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis. The FDA has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of the effectiveness or safety of a four-dose regimen of HEPLISAV-B. The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which prevents infection caused by all known subtypes of hepatitis B virus in adults. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLISAV-B regimen for the adult hemodialysis population.

On February 20, 2025, the Company announced HEPLISAV-B® 2024 net product revenue grew 26% year-over-year to $268 million; net product revenue is expected to be $305 to $325 million in 2025.

Emeryville, California-based Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines. Dynavax has worldwide commercial rights to HEPLISAV-B. On May 9, 2024, the Company announced HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024. It also reaffirmed the full-year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million. HEPLISAV-B's total market share in the U.S. increased to approximately 44%, compared to about 35% at the end of 2022.

Heplisav-B Pricing

The retail price ranges from $131 to $160. Most insurance plans will cover this vaccine; however, some discounts can be found to reduce the cost of the vaccine.

Heplisav-B Indication

In 2022, the U.S. CDC issued a universal recommendation that adults aged 19-59 receive hepatitis B vaccination. The Heplisav-B vaccine is indicated for preventing infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Hepatitis B is a viral liver disease that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent it. In adults, hepatitis B is spread through infected blood and unprotected sex with an infected person. 

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following the administration of HEPLISAV-B. In addition, immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

On December 15, 2020, the U.S. Preventive Services Task Force published a final recommendation on screening for hepatitis B virus infection in adolescents and adults. Based on its review of the evidence, the Task Force recommends that clinicians screen teens and adults at increased risk of hepatitis B infection to help prevent serious health problems.

Heplisav-B and HIV

With rising transmission, the hepatitis B virus is 50 to 100 times more infectious than HIV. The NIH phase 3 study, "High HBsAb seroprotection achieved four weeks after three doses of HepB-CpG vaccine in people living with HIV (PLWH) without prior HBV vaccination. According to the findings, all participants achieved seroprotection, with 88% achieving HbsAb levels greater than 1000 mIU/mL. High antibody levels are thought to be associated with long-term vaccine durability. Eight weeks after the second dose, 94.4% of participants achieved seroprotection; this percentage increased to 98.5% by week 24 before the third dose. The most common side effects of vaccination were injection site pain, malaise, fatigue, muscle aches, and headaches.

Heplisav-B Vaccine Dosage

The Heplisav-B vaccine is administered by intramuscular injection in the deltoid region. It is a 2-dose series given one month apart. Heplisav-B may not prevent hepatitis B infection in individuals with an unrecognized hepatitis B infection at the time of vaccine administration. For the complete U.S. Prescribing Information for HEPLISAV-B, click here.

Heplisav-B Vaccine Side Effects

The most common patient-reported adverse reactions reported within seven days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%). Therefore, do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. In addition, appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following the administration of HEPLISAV-B.

Heplisav-B Vaccine News

February 20, 2025 - Ryan Spencer, Chief Executive Officer of Dynavax commented, "Looking ahead to 2025, we plan to drive significant top-line growth as we continue to establish HEPLISAV-B as the market share leader in the expanding hepatitis B vaccine market in the U.S.

January 8, 2024 - Ryan Spencer, Chief Executive Officer of Dynavax, stated, "Turning to this year, we believe HEPLISAV-B is well-positioned entering 2024, supported by significant market share gains in the total market and key market segments. We remain extremely confident in the long-term growth of the hepatitis B market, with HEPLISAV-B expected to achieve a majority market share in the U.S."

February 28, 2023 - Ryan Spencer, Chief Executive Officer of Dynavax, stated in a press release, "We are very pleased that HEPLISAV B has received this latest approval and look forward to ongoing discussions with potential commercial partners for Great Britain. This approval highlights the capabilities and continued successful execution of the organization."

October 20, 2022 - The U.S. NIH published: A three-dose hepatitis B vaccine regimen protects people with HIV.

August 4, 2022 - "During the second quarter, we continued to execute on our key priorities successfully and are on track for another profitable year with record revenues for both HEPLISAV-B and CpG 1018 adjuvant," commented Ryan Spencer, Chief Executive Officer of Dynavax.

March 25, 2022 - An Original Investigation published by the JAMA Network: Association Between 2-Dose vs. 3-Dose Hepatitis B Vaccine and Acute Myocardial Infarction. In this prospective cohort noninferiority study of 31,183 recipients of the HepB-CpG vaccine and 38,442 recipients of the HepB-alum vaccine, rates of acute MI per 1000 person-years were 1.67 and 1.86, respectively. The upper confidence limit for the adjusted hazard ratio was 1.32, less than the noninferiority margin of 2. This means the receipt of HepB-CpG compared with HepB-alum was not significantly associated with an increased risk of acute myocardial infarction.

November 4, 2021 - The Hepatitis B Foundation applauds yesterday's vote by the U.S. U.S. Advisory Committee on Immunization Practices to recommend universal hepatitis B vaccination for all adults ages 19 to 59 in the U.S. Adults 60 and older are advised to follow risk-based guidelines to determine if they should receive the vaccine.

November 3, 2021 - The U.S. CDC's vaccine committee presented Universal Adult Hepatitis B Vaccination: Introduction.

September 29, 2021 - The U.S. CDC's vaccine committee presented Evidence to Recommendations Framework: Should all HepB-unvaccinated adults receive hepatitis B vaccination?

May 27, 2021 - Dynavax Technologies announced it has entered into a commercialization agreement with Bavarian Nordic to market and distribute the HEPLISAV B Vaccine in Germany, with an expected launch in the fourth quarter of 2021. Bavarian Nordic is a fully integrated vaccine company that develops, manufactures, and commercializes life-saving vaccines. 

April 27, 2021 - Dynavax Technologies Corporation announced the post-marketing study results assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results show no increased risk of AMI associated with vaccination with HEPLISAV-B compared to Engerix-B.

February 19, 2021 - Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B.

January 7, 2021 - Dynavax Technologies Corporation announced the final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. In this clinical trial, final immunogenicity data in 119 patients evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease undergoing hemodialysis demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintaining protection in patients undergoing hemodialysis. In addition, interim safety data showed HEPLISAV-B is well tolerated, and no safety concerns were observed. 

December 10, 2020 - Dynavax Technologies Corporation announced that the European Medicines Agency Committee for Medicinal Products for Human Use had issued a positive opinion on the Company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. 

April 28, 2020 - Dynavax Technologies Corporation reported immunogenicity and safety data from an interim analysis of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis showed HEPLISAV-B has well tolerated a seroprotection rate of 86.4% in 44 patients.

Heplisav-B Clinical Trials

Heplisav-B has been involved in 11 clinical trials to test the vaccine's safety and efficacy.

This phase III/IV study will evaluate the response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders (Group A) and individuals who are naïve to HBV vaccination (Group B).

Clinical Trial NCT04199715: Phase 1 Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients.

Clinical Trial NCT04385524: Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection. Last Update Posted: May 13, 2020.

0 min read
Manufacturer: 
Dynavax
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Heplisav-B Hepatitis B Vaccine
VIS: 
PDF
Availability: 
U.S. FDA, Europe, UK, Germany
Clinical Trial: 
https://www.heplisavb.com/study-results
Drug Class: 
Vaccine
Clinical Trial Phase I: 
Phase 1 Clinical Trial Heplisav-B in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
Clinical Trial Phase II: 
HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor
Clinical Trial Phase III: 
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B (BEe-HIVe)
Lab Test: 
CDC
Condition: 
Hepatitis B
Availability Link: 
Dynavax
Last Reviewed: 
Friday, February 21, 2025 - 10:35
Brand: 
Heplisav B
Status: 
Approved
Manufacturer Country ID: 
US
Kosher: 
Yes
Halal: 
Yes
Side Effects: 
EMA
Ingredients: 
Company
Countries: 
USA
Europe
UK
Germany
Rate Vaccine: 
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Havrix Hepatitis A Vaccine

Havrix Hepatitis A Vaccine

Havrix inactivated vaccine is a sterile suspension of inactivated virus strain HM175, propagated in MRC-5 human diploid cells. The cells are lysed after removing the cell culture medium to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Initial U.S. Approval: 1995; Proper Name: Hepatitis A Vaccine, Inactivated: STN: BL 103475, BL 103475/5740 updated October 27, 2023.

Anyone not vaccinated or previously infected can get infected with the hepatitis A virus. The WHO estimates that in 2016, 7,134 persons died from hepatitis A worldwide.

Learn more about GlaxoSmithKline Biologicals (GSK) hepatitis vaccines. 

Havrix Hepatitis A Vaccine Indication

HAVRIX is a vaccine for active immunization against disease caused by the hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary vaccination should be administered at least two weeks before exposure to HAV. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine or any component of HAVRIX, including neomycin, is a contraindication to administering HAVRIX.

Havrix Hepatitis A Vaccine Immunocompromised

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to HAVRIX. Vaccination with HAVRIX may not protect all vaccine recipients, says GSK.

Havrix Hepatitis A Vaccine Dosage

Havrix is administered by intramuscular injection. Children and adolescents: A single 0.5-mL dose and a 0.5-mL booster dose were administered 6 to 12 months later. Adults: A single 1-mL dose and a 1-mL booster dose administered between 6 to 12 months later. Primary immunization should be administered at least two weeks before exposure to HAV.

Havrix Hepatitis A Vaccine Adverse Reactions

In clinical trials with HAVRIX in children 11 to 25 months of age, the most common solicited adverse reactions were injection-site pain and redness, irritability, drowsiness, and appetite loss. In clinical trials with HAVRIX in adults and children two years of age and older, the most common solicited adverse reactions were injection-site soreness and headache.

Havrix Hepatitis A Vaccine News

December 19, 2018 - The U.S. FDA approved the request dated June 19, 2018, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Hepatitis A Vaccine Inactivated (Havrix®), manufactured at your Belgium facility to update Section 8 of the package insert to comply with 21 CFR 201.57(c)(9)(i)-(iii) to address the Pregnancy, Lactation, and Labeling Rule.

 

0 min read
Manufacturer: 
GSK
Reviewer: 
Robert Carlson, MD
Vaccine: 
Havrix Hepatitis A Vaccine
VIS: 
PDF
Availability: 
Available
Generic: 
Hepatitis A vaccine
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase III: 
Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-C)
Clinical Trial Phase IV: 
Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel
Lab Test: 
CDC
Condition: 
Hepatitis A
Last Reviewed: 
Friday, February 16, 2024 - 12:40
Brand: 
HAVRIX
Accession Number: 
DB10989
Status: 
Approved
Manufacturer Country ID: 
UK
Kosher: 
Yes
Side Effects: 
GSK
Ingredients: 
GSK
Countries: 
USA
UK
New Zealand
Rate Vaccine: 
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Gardasil 9 HPV Vaccine

Gardasil 9 HPV Vaccine Clinical Trials, Dosage, Indication, Side Effects, Usage

Merck's GARDASIL 9® vaccine protects people ages 9 to 45 against the following diseases caused by nine types of human papillomavirus (HPV): cervical, vaginal, and vulvar cancers in females, anal cancer, specific head and neck cancers, and genital warts in both males and females. The Gardasil 9 vaccine consists of HPV proteins, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58, as well as amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, Polysorbate 80, sodium borate, and water for injection.

In 2021, the US Food and Drug Administration (FDA) approved an expanded indication to include oropharyngeal and other head and neck cancers caused by HPV. On April 11, 2022, Health Canada approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age for the prevention of infection caused by HPV and the following diseases associated with the HPV types included in the vaccine: Oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. Additionally, the U.S. Centers for Disease Control and Prevention (CDC) says that men can get HPV, causing anal and throat cancers and genital warts. 

Additionally, the CDC's vaccine committee reviewed an updated presentation on June 22, 2022, regarding HPV vaccination coverage and the impact of the US HPV vaccination program. GARDASIL 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV. GARDASIL 9 does not prevent all types of cervical, vulvar, vaginal, anal, or head and neck cancers. A study published on May 31, 2023, concluded there is strong evidence for high VE against anal HPV infection and AIN in HIV-negative individuals vaccinated at age ≤26 years.

On September 5, 2023, Merck announced that data showed sustained HPV antibody responses ten years after the third dose in boys and girls. Across GARDASIL 9-targeted HPV types, antibody assessments, as evaluated by geometric mean titers, peaked at Month 7 and decreased after 12 months. The vast majority of study participants remained seropositive at the end of the study period, with 99.6% to 100% of participants seropositive for the targeted HPV types at Month 7, as determined by the HPV-9 competitive Luminex immunoassay. Additionally, 81.3% to 97.7% of participants remained seropositive for the same HPV types at Month 126, depending on the specific HPV type. Based on the HPV-9 immunoglobulin G Luminex immunoassay, 94.9% to 100% of participants were seropositive at Month 126.

On March 13, 2024, the company announced plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of the World Health Organization-endorsed single-dose HPV regimen compared to the approved GARDASIL®9 three-dose regimen. Additionally, Merck announced plans to initiate clinical development of an investigational multivalent HPV vaccine designed to provide broader protection against multiple types of HPV. On May 23, 2025, Merck published a dosing statement, stating that Merck maintains that until there are sufficient data to enable the US Food and Drug Administration (FDA) and the European Commission to license an alternative dosing regimen for GARDASIL 9, the CDC recommendation should remain consistent with the approved product labeling. The 2- and 3-dose regimens currently described in the US and European Union product labeling were evaluated in extensive clinical studies that met the standards of regulatory agencies and underwent extensive evaluation through the regulatory approval process. The FDA approved GARDASIL in 2006 and GARDASIL 9 in 2014. The vaccines have over 18 years and 10 years of real-world experience, respectively.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., produces Gardasil 9 vaccines. Merck announced that GARDASIL/GARDASIL 9 sales declined 41% to $1.3 billion in First-Quarter 2025. IN 2024, sales reached $8.6 billion.

Gardasil 9 Indication

Gardasil 9 helps protect women ages 9 to 45 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by nine types of HPV. Gardasil 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. In Japan, administration of a 3-dose regimen of GARDASIL 9 in young men reduced the combined incidence of anogenital persistent infection caused by nine types of HPV compared with a placebo.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on its effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Most sexually active persons become infected with HPV at least once. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 100 types of HPV have been identified, 40 of which can infect the genital area. Most HPV infections are self-limited and are asymptomatic or unrecognized. However, many females with cervical cancers were probably exposed to cancer-causing HPV types in their teens and early 20s.

Gardasil 9 Effecicy

On November 27, 2024, JAMA published a Research Letter concluding that studies from 2022 and 2023 indicated a 12% annual decline (overall, a 65% reduction) in cervical cancer incidence among US women younger than 25 from 2012 to 2019, who likely benefited from HPV vaccination. In January 2025, Public Health Scotland announced that no cervical cancer cases had been detected in fully vaccinated women following the HPV immunization at age 12-13.

Gardasil 9 Dosage - US.

The US CDC now recommends that 11 —to 12-year-olds get two doses of the HPV vaccine—rather than the previously recommended three doses—to protect against cancers caused by HPV. The second dose should be given 6-12 months after the first dose. Each dose of Gardasil 9 is 0.5 mL and is administered intramuscularly only. The Age-Recommended Regimen Schedule is as follows: 9 through 14 years—2 doses at 0, 6 to 12 months; 15 through 45 years—3 doses at 0, 2, and 6 months.

Gardasil 9 Dosage UK.

The rollout of the 9-valent vaccine is scheduled to commence in 2022. The 9-valent HPV vaccine is JCVI's preferred vaccine for the routine adolescent program because of the additional protection against the five cancer-causing HPV types. On August 5, 2022, the UK's JCVI endorsed a one-dose HPV 9 regimen. 

Gardasil 9 and HIV

A peer-reviewed study published on October 1, 2022: Prevalence and Risk Factors of Anal HPV Infection in MSM Living With HIV: Identifying the Target Groups to Prioritize for Immunization, concluded that MSM with HIV would benefit from Gardasil 9 immunization.

Gardasil 9 Adverse Events

Anyone who is allergic to the ingredients of Gardasil 9, including those severely allergic to yeast, should not receive the vaccine. Gardasil 9 was not studied in women who knew they were pregnant. On April 5, 2021, the JAMA published a study, 'Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes.' In this cohort study of 1,493 pregnancies, in adjusted analyses, during-pregnancy or peripregnancy exposures to the 9vHPV vaccine were not associated with spontaneous abortion. In addition, 9vHPV vaccine exposures during or around pregnancy were not associated with adverse birth outcomes among live births.

Gardasil 9 Side Effects

Gardasil 9 side effects may include pain, swelling, redness, itching, bruising, bleeding, a lump at the injection site, headache, fever, nausea, and dizziness. Fainting can happen after getting Gardasil 9. Sometimes, people who faint can fall and hurt themselves. For this reason, healthcare professionals may ask your child to sit or lie down for 15 minutes after they receive Gardasil 9. Some people who faint might shake or become stiff.

Gardasil 9 Price

The US CDC Vaccine Price List was last updated in 2025.

Gardasil 9 Vaccine News

May 23, 2025 - Merck affirmed its position regarding alternate dosing regimens for GARDASIL®9 Vaccine for the prevention of certain HPV-related cancers and diseases. HPV vaccination has an established legacy of substantial public health impact using the currently licensed regimens, including documented reductions in certain HPV-related cervical cancers at a population level.

February 4, 2025 - Robert M. Davis, Chairman and Chief Executive Officer of Merck, stated, "We're continuing to progress our pipeline, advance key clinical programs, and augment our pipeline through promising business development."

January 8, 2025 - Merck announced that China's National Medical Products Administration approved GARDASIL® for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases.

September 11, 2024 - "A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

March 13, 2024 - "Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health," said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories.

October 27, 2022—Merck confirmed that China's National Medical Products Administration approved GARDASIL 9 in September 2022 for use in girls and women aged 9 to 45. The vaccine was previously approved for use in women ages 16 to 26.

April 11, 2022 - The WHO announced that the one-dose HPV vaccine is effective in protecting against cervical cancer.

November 29, 2021—The JAMA Pediatrics published a Research Letter titled "Human Papillomavirus Vaccination and Trends in Cervical Cancer Incidence and Mortality in the US." The letter found a 38% decrease in cervical cancer incidence and a 43% decline in mortality among women after HPV vaccination.

March 11, 2021 - PLOS published a cost-effectiveness analysis using the Cancer Intervention and Surveillance Modeling Network models to evaluate the cost-effectiveness of extending HPV vaccination to females and males up to 30, 35, 40, or 45 years. This study found that HPV vaccination of women and men aged 30 to 45 provides limited health benefits at the population level at a substantial cost (HPV vaccine prices).

February 1, 2021: The US CDC published research in Volume 27, Number 3, March 2021, titled "Oral Human Papillomavirus Infection in Children during the First 6 Years of Life, Finland." Children acquire their first oral HPV infection at an early age, and the mother's HPV status significantly impacts the outcome of oral HPV persistence for her offspring.

October 5, 2018 - FDA approved your request dated April 6, 2018, to supplement your Biologics License Application (B.L.A.) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL® 9) to extend the age range for the use of the vaccine to include women and men from 27 to 45 years of age.

February 9, 2018 - The FDA approved your request dated August 11, 2017, to supplement your Biologics License Application (B.L.A.) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9®), to revise Sections 2.3 and 14.4 of the Gardasil 9® package insert to clarify information regarding the study conducted to assess the safety and immunogenicity of Gardasil 9® in individuals who were previously vaccinated with Gardasil®.

December 16, 2016—The CDC report includes new recommendations for using a 2-dose schedule for girls and boys who initiate the vaccination series at ages 9 through 14. Three doses remain recommended for immunocompromised persons and those who start the series at ages 15 through 26.

Gardasil®9 HPV Vaccine Clinical Trials

Phase 4 study—NCT03943875—Sponsor: The University of Texas Medical Branch, Galveston; Collaborator: Cancer Prevention Research Institute of Texas. We evaluate whether 15-26-year-old males and females require a third dose of the HPV vaccine, or whether two doses provide similar protection to three doses from the nine types of HPV it protects against. The estimated Primary Completion Date is February 28, 2022. 

0 min read
Manufacturer: 
Merck
Reviewer: 
Robert Carlson, MD
Vaccine: 
Gardasil 9 HPV Vaccine
VIS: 
PDF
Availability: 
Worldwide
Generic: 
Human Papillomavirus 9-valent Vaccine, Recombinant
Clinical Trial: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636904/
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
FDA
Clinical Trial Phase II: 
Immunogenicity and Safety of Gardasil-9 and Cervarix
Clinical Trial Phase III: 
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Clinical Trial Phase IV: 
3 Dose vs. 2 Dose With Delayed 3rd Dose
Lab Test: 
Cervical Cancer Tests
Condition: 
HPV
Availability Link: 
Merck
Last Reviewed: 
Friday, July 4, 2025 - 05:55
Brand: 
Gardasil 9
Abbreviation: 
HPV9
CPT Code: 
90651
Accession Number: 
DB10300
Status: 
Approved
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
Kosher: 
Yes
Halal: 
Yes
Side Effects: 
Gardasil 9 Side Effects
Ingredients: 
Gardasil 9 Ingredients
Countries: 
USA
UK
Canada
Europe
Ireland
Mexico
Jamaica
Bahamas
Singapore
France
Bermuda
Cayman Islands
Cuba
Brazil
Portugal
China
India
UNII: 
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Rate Vaccine: 
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Location tags: 
United States of America
China