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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.  

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.

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.

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.