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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. 

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

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

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

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

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

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

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

Denvaxia Vaccine Availability

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

Dengvaxia Pre-Vaccination Test

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

Dengvaxia Vaccine Efficacy

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

Dengvaxia Vaccine Price

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

Dengvaxia Vaccine Indication

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

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

Dengvaxia Vaccine Immunocompromised Individuals

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

Dengvaxia Vaccine Pregnancy and Breastfeeding

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

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

Dengvaxia Vaccine Dosage

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

Dengvaxia Vaccine Limitations

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

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

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

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

Dengvaxia Vaccine Side Effects

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

Dengvaxia Tests

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

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

Dengvaxia Vaccine Legal Issues

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

Dengvaxia Vaccine News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dengvaxia Dengue Vaccine Clinical Trials

Dengvaxia is currently involved in several different clinical trials.

ASP3772 Pneumococcal Vaccine

Affinivax ASP3772 vaccine candidate offers cell (antibody) and T-cell immune protection against Streptococcus pneumoniae. ASP3772 includes 24 pneumococcal polysaccharides and two conserved pneumococcal proteins. ASP3772 utilizes the Multiple Antigen Presenting System (MAPS) platform, Affinivax’s proprietary, next-generation vaccine technology. The MAPS tech ology platform uses proprietary chemistry that capitalizes on the highly specific, durable, non-covalent affinity binding between biotin and rhizavidin, a biotin-binding protein.

The highly stable MAPS complex creates affinity binding and creates tributes to a simple, modular, and efficient approach to developing novel vaccines and immunotherapies. Conventional vaccine conjugation technology seeks to optimize the generation of protective antibody responses mainly to polysaccharide antigens, using the protein antigen as a carrier. In stark contrast, a MAPS vaccine can present both the polysaccharide and the protein antigens to the host immune system to induce bot- and T-cell immune response.

On July 13, 2021, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for ASP3772 to prevent pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. The results formed the FDA's decision regarding the Phase 2 data. The design is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

In May 2022, GlaxoSmithKline plc (GSK) pledged $2.1 billion and up to $1.2 billion in development milestone payments to take over Affinivax Inc. For more information, visit www.affinivax.com. Affinivax Hea quarters is located at 301 Binney St., Suite 302, Cambridge, MA 02142.

ASP3772 Pneumococcal Vaccine Indication 

ASP3772 is a vaccine candidate that offers the potential to provide broader protection against pneumococcal disease. Streptococcus pneumoniae is a bacterium frequently found in the upper respiratory tract of healthy children and adults and can cause serious infections ranging from pneumonia, meningitis, and sepsis, representing a major global health problem.

ASP3772 Pneumococcal Vaccine Dosage

Study participants received a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.

ASP3772 Pneumococcal Vaccine Development News

July 13, 2021—Affinivax, Inc. and Astellas Pharma Inc. announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae. The results demonstrated that ASP3772 was well tolerated. ASP3772 also exhibited an antibody response to each of the 24 polysaccharides and an additional antibody response to the conserved pneumococcal proteins.

April 23, 2020:  Affinivax Announces $120 Million Series B Financing to Advance Pipeline of Novel MAPS Vaccines and Immunotherapies.

February 13, 2019: The first subject was dosed with ASP3772, a novel MAPS vaccine targeting Streptococcus pneumoniae (pneumococcal). This followed the successful submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in December 2018.

February 28, 2017: Affinivax, Inc. and Astellas Pharma Inc. announced they have entered into an exclusive worldwide license agreement to develop and commercialize a vaccine targeting Streptococcus pneumoniae (pneumococcus).

ASP3772 Pneumococcal Vaccine Clinical Trials

The ASP3772 clinical development program includes indications for protection against Streptococcus pneumoniae infections in boults and infants. The clinical trials can be found here.