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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. 

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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: 
Z845VHQ61P
Rate Vaccine: 
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Location tags: 
United States of America
China

Gardasil HPV Vaccine

Gardasil HPV Vaccine 2022

Merck's Gardasil vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water.

Gardasil is endorsed by the WHO, which says HPV vaccines prevent cervical cancer by preventing infection by various HPV types. However, Gardasil is not available in the U.S., as Gardasil 9 is the featured HPV vaccine in the U.S.

The U.S. FDA initially approved Gardasil for use in the USA on June 8, 2006, and a final approval letter was issued on April 24, 2015. Gardasil 2-dose vaccination series was approved by the U.S. CDC's Advisory Committee on Immunization Practices (ACIP) for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11.

On November 7, 2022, Merck, known as MSD outside of the U.S. and Canada, announced that an updated systematic literature review examining the global impact and effectiveness of HPV vaccination using GARDASIL was published in the journal Expert Review of Vaccines. This systematic review observed that the use of GARDASIL led to reductions in the rates of high-grade (precancerous) and low-grade cervical lesions, as well as reductions in certain non-cervical HPV-related diseases and HPV infections in women and men. The systematic review included 138 peer-reviewed studies published between March 1, 2016, and March 31, 2020. It details the impact and effectiveness of GARDASIL through immunization programs in 23 countries across Africa, Asia, Europe, Australia, South America, and North America and builds on a prior review of real-world data published in 2016. Studies examining GARDASIL 9® (Human Papillomavirus 9-valent Vaccine, Recombinant) were not included in this review.

Merck & Co., Inc. is an American multinational pharmaceutical company based in New Jersey and one of the world's largest pharmaceutical companies.

Gardasil Indication

Gardasil is a vaccine that prevents diseases caused by 4 HPV types included in the vaccine. HPV vaccination is recommended for all preteens (including girls and boys) at ages 11–12 years. All preteens need HPV vaccination to protect them from HPV infections that can cause cancer later in life.

The Gardasil vaccine is an important cervical cancer prevention tool that will potentially benefit millions of women's health. About 12,000 women are diagnosed with cervical cancer annually, and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is women's second most common cancer, causing 470,000 new cases and 233,000 deaths annually.

Based on the FDA and CDC's review of available information, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. Therefore, the CDC has not changed its recommendations for the use of Gardasil. Likewise, the FDA has not changed the prescribing information for how the vaccine is used. 

Gardasil U.K. Dosage

Gardasil was offered in the U.K. in September 2012 as a 3-dose course. However, after a review of the data by JCVI, this was revised in 2014 to a 2-dose course for the routine program for girls up to and including the age of 14. After reviewing further data, the JCVI will be issuing interim advice on moving to a one-dose schedule for the routine adolescent program.

Gardasil Side Effects

People rarely have a more severe allergic reaction, called an anaphylactic reaction, immediately after HPV vaccination.

Gardasil Sales 2021 - 2022

Merck & Co. reported on February 3, 2022, during the fourth quarter of 2021, GARDASIL/GARDASIL 9 sales grew 53% to $1.5 billion, primarily driven by strong global demand, particularly in China, which also benefited from increased supply. Fourth-quarter 2021 GARDASIL/GARDASIL 9 sales growth was partially offset by lower sales in the U.S. due to the timing of public sector purchases, as well as the replenishment in the fourth quarter of 2020 of doses that were borrowed from the U.S. CDC Pediatric Vaccine Stockpile, which increased fourth-quarter 2020 sales by $120 million.

Gardasil News For 2021-2022

November 25, 2022 - Kiwi mums undecided about 'anti-cancer' HPV vaccine. University of Auckland pediatrics professor and paper author Cameron Grant​ said this was concerning, as Māori and Pasifika have higher rates of cervical cancer and related fatalities.

November 7, 2022 - "Since its first authorization in 2006, GARDASIL has been widely used in national immunization programs all around the world, which has enabled researchers to study the impact of HPV vaccination in a broad range of populations and settings," said Ravinder Dhawan, vice president, head of the center for observational and real-world evidence, Merck Research Laboratories. "These real-world data from more than one hundred published studies show decreases in vaccine-type HPV infections and related diseases and are an important reminder that we need to do more to expand vaccination to males and females as part of the global fight to lessen the incidence of certain HPV-related diseases and cancers."

April 28, 2022 - Merck announced GARDASIL and GARDASIL 9 Sales Grew 59% to $1.5 Billion; Excluding the Impact From Foreign Exchange, Sales Grew 60%.

December 16, 2021 - GAVI reported in Kenya, Africa, HPV is the second cause of cancer among women between 15 and 44 years, with approximately 5,250 cases diagnosed yearly. In October 2019, Kenya announced plans to have more than 800,000 girls protected against cervical cancer by introducing the HPV vaccine.

November 12, 2021 - The Lancet published a study funded by Merck: Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomized, placebo-controlled, phase 3 trial. Study Interpretation - The quadrivalent HPV vaccine protects against anogenital disease related to HPV6, 11, 16, and 18. The results support quadrivalent HPV vaccination in men, including catch-up vaccination.

October 8, 2021 - A cohort phase 4 study in India compared the HPV vaccine efficacy of single-dose to that of three and two doses in protecting against persistent HPV 16 and 18 infection at ten years post-vaccination. Vaccine efficacy against persistent HPV 16 and 18 infections among participants evaluable for the endpoint was 95·4% (95% CI 85·0–99·9) in the single-dose default cohort (2135 women assessed), 93·1% (77·3–99·8) in the two-dose cohort (1452 women assessed), and 93·3% (77·5–99·7) in three-dose recipients (1460 women considered).

September 17, 2021 - Original Research: Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States was published by the JAMA Network. Safety concern has been identified as a primary barrier to initiating the human papillomavirus (HPV) vaccine in the US. However, it is unclear if the public's sentiment concerning HPV vaccine safety aligns with postmarketing vaccine safety surveillance data. Conclusions and Relevance  In this descriptive cross-sectional study, a rise in citing safety concerns were observed among parents with HPV vaccine hesitancy, contrary to the severe and nonserious AE reporting trends. These findings suggest an urgent need to combat the rising sentiment of safety concerns among caregivers to increase HPV vaccine confidence.

August 31, 2021 - Fierce Pharma reported Merck's HPV vaccine Gardasil 9, which saw an 11% annual price hike, according to Bernstein analysts. Gardasil 9 and its sister shot Gardasil were hit particularly hard during the pandemic as patients delayed doctor visits and prioritized COVID-19 jabs. However, those vaccines have started their comeback, as sales jumped 88% during the second quarter to $1.23 billion.

August 28, 2021 - The Lancet published a study that found, 'Reassuringly, our large well-controlled study does not support that human papillomavirus vaccination increases the risk of non-targeted infectious disease in any clinically meaningful way. While our study does not provide evidence against adverse effects of other non-live vaccines, it does provide evidence against the claim that all non-live vaccines increase the risk of heterologous infections in females.'

August 8, 2021 - Thailand confirmed that all HPV vaccines registered had been certified by the Institute of Biological Products, Department of Medical Sciences.

Gardasil Clinical Trials

Gardasil has been tested in over 195 clinical trials, studying the vaccine's safety, effectiveness, and immunogenicity.

Clinical Trial NCT00923702 - Vaccinated participants were recruited between Sept 1, 2009, and April 8, 2010, and followed up over a median duration of 9 years. Four thousand three hundred forty-eight participants had three doses, 4,980 had two doses (0 and 6 months), and 4,949 had a single dose. 

Interpretation: A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses.

0 min read
Manufacturer: 
Merck
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Gardasil HPV Vaccine
VIS: 
PDF
Availability: 
Not in the USA
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase III: 
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Clinical Trial Phase IV: 
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls (HPV CSP01)
Lab Test: 
CDC
Condition: 
HPV
Last Reviewed: 
Friday, December 9, 2022 - 06:35
Brand: 
Gardasil
CPT Code: 
90649
Accession Number: 
DB10300
Status: 
Approved
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
Kosher: 
Yes
Side Effects: 
FDA
Ingredients: 
FDA
Countries: 
Thailand
UK
Mexico
India
Canada
Kenya
UNII: 
Z845VHQ61P
Rate Vaccine: 
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Fluzone Influenza Vaccine

Fluzone® Influenza Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Sanofi Pasteur's Fluzone® Quadrivalent influenza vaccine contains influenza A and B strains identified for the current flu season. The Fluzone vaccine is given to people six months of age and older. The Fluzone High-Dose vaccine contains four killed flu virus strains for people 65 and older. In addition, Fluzone High-Dose has four times the antigen (the part of the vaccine that helps your body build up protection against flu viruses) of standard-dose inactivated influenza vaccines. Sanofi says the higher dose of antigen in the vaccine is intended to give older people a better immune response and better protection against the flu.

Sanofi Pasteur produces influenza vaccines each year across five international sites: Swiftwater (Pennsylvania, United States), Pearl River (New York, United States), Val-de-Reuil, Ocoyoacac (Mexico), and Shenzhen (China). As the largest manufacturer of influenza vaccines globally, Sanofi has continuously invested in expanding manufacturing capabilities and will distribute more than 250 million doses of influenza vaccines globally in 2020.

​​​​​Fluzone Quadrivalent and Fluzone High-Dose vaccines help prevent influenza disease caused by influenza A and B strains contained in each vaccine. It is approved to help protect eligible people six months and older. Fluzone High-Dose is formulated for people 65 years and older, including four times the standard dose. It's proven 24.2% more effective than the standard-dose Fluzone vaccine in preventing the flu.

As of 2024, the Fluzone High-Dose Quadrivalent vaccine (STN: 103914, updated Nov. 2023) has shown better protection than standard-dose flu shots in older adults. Canada's National Advisory Committee on Immunization's annual Statement on Seasonal Influenza Vaccine for 2024-2025 recommends Fluzone® among the preferential influenza vaccines to protect seniors against influenza.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Fluzone Vaccine Price

Sanofi Pasteur provides a coding and reimbursement guide for healthcare providers. According to CMS.gov 2022-2023 flu season payment allowance, the Fluzone High-Dose price is $69.94.  Fluzone Quadrivalent is priced at $21.52. 

Fluzona Dose and Schedule

Fluzone High-Dose Quadrivalent should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 and older. The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas with a major nerve trunk. Do not administer this product intravenously.

Fluzone Safety

Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any vaccine component (including eggs or egg products for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent) or after a previous dose of the vaccine. In addition, Fluzone vaccines should not be given to anyone with a severe allergic reaction after the last dose of any influenza vaccine.

Fluzone and COVID-19 Vaccines

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

Fluzone Vaccine Side Effects

Fluzone vaccines are generally well-tolerated. In adults >65 years of age, the most common (>10%) injection-site reaction was pain (41.3%); the most common solicited systemic adverse reactions were myalgia (22.7%), headache (14.4%) and malaise (13.2%). If you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS. VAERS is a U.S. passive reporting system that relies on individuals to send reports of their experiences with a vaccine. However, anyone, including parents and patients, can submit information to VAERS. Furthermore, healthcare providers are required by law to report to VAERS.

Fluzone Immunocompetence

If Fluzone High-Dose Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected.

Fluzone Lactation and Pregnancy

There are limited human data on Fluzone High-Dose and no animal data available on Fluzone High-Dose Quadrivalent to establish whether there is a vaccine-associated risk with the use of Fluzone High-Dose Quadrivalent in pregnancy. No human or animal data are available to assess the effects of Fluzone High-Dose Quadrivalent on the breastfed infant or milk production/excretion.

Fluzone Vaccine News

July 26, 2024 - The National Advisory Committee on Immunization's (NACI) annual Statement on Seasonal Influenza Vaccines for 2024-2025 continues to recommend Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines over standard-dose influenza vaccines to protect adults 65 years of age and older against influenza.

January 3, 2024 - Delphine Lansac, General Manager, Vaccines Canada, Sanofi, stated in a press release, "This long-standing recommendation as a preferential influenza vaccine for adults 65 years of age and older speaks to the science that Fluzone® High-Dose Quadrivalent is built on and demonstrates our continued leadership in vaccines. It's been a groundbreaking year, where over 50% – more than one in two – seniors who received influenza vaccines in Canada were immunized with Fluzone®."

September 13, 2023 - Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi, commented in a press release, "The flu can be a serious public health threat and lead to complications such as heart attack, stroke, and pneumonia. These can be especially dangerous for older adults, ethnic and racial minority groups at an increased risk of being hospitalized from the flu, and those living with chronic conditions like asthma, diabetes, and heart disease. Our hope is that, as a part of our annual commitment to educating the public about the flu, this campaign will increase awareness of the importance of flu vaccination and remind older adults and at-risk populations that there are vaccines available to them that may provide better protection for their specific needs, such as Fluzone High-Dose Quadrivalent  or Flublok Quadrivalent."

June 17, 2021 - The U.S. Food and Drug Administration Center for Biologics Evaluation and Research has approved Sanofi Pasteur, Sanofi's vaccines global business unit, for an additional influenza manufacturing facility in Swiftwater, PA.

March 8, 2021 - Certain patients have an increased risk of influenza infections and poor serologic response to standard influenza vaccination. A new study found that high-dose influenza vaccination leads to more robust and durable seroprotection in high-risk patients.

October 7, 2020 - High-dose flu vaccine is in short supply. The CDC recommends getting the regular dose if the high-dose vaccine is unavailable.

Fluzone Influenza Clinical Trials

Fluzone has been tested in over 150 clinical trials.

0 min read
Manufacturer: 
Sanofi Pasteur, Ltd.
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Fluzone Influenza Vaccine
VIS: 
PDF
Availability: 
USA, UK, Canada, Germany, and various countries
Generic: 
Influenza Vaccine
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase II: 
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years
Clinical Trial Phase III: 
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Clinical Trial Phase IV: 
Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children
Lab Test: 
Influenza A and B Antigen, DFA
Condition: 
Influenza
Availability Link: 
Flu Vaccine Locator
Last Reviewed: 
Friday, July 26, 2024 - 13:10
Brand: 
Fluzone
CPT Code: 
90688
Accession Number: 
DB15703
Status: 
Approved
Manufacturer Country ID: 
US
Kosher: 
Yes
Halal: 
Yes
Side Effects: 
Warnings and Precautions
Ingredients: 
Fluzone Ingredients
Countries: 
Canada
USA
UK
Germany
UNII: 
NY1FF92M1E
Cell Line Production: 
Chicken Eggs
Rate Vaccine: 
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FluMist Influenza Vaccine

FluMist® Influenza Vaccine Clinical Trials, Dosage, Indication, Side Effects

AstraZeneca's FluMist® (Fluenz® Tetra) Influenza Vaccine Live, Intranasal contains weakened live viruses that trigger an immune response in the nose, where people usually catch the flu, says the U.S. Centers for Disease Control and Prevention (CDC). FluMist nasal vaccine works in the nose, cells, and bloodstream to help provide flu protection within 14 days. FluMist then triggers people's immune systems to build defenses (called antibodies) for individuals aged 2-49 years. 

FluMist is the only U.S. Food and Drug Administration (FDA)-approved (STN: 125020) flu vaccine with a needle-free nasal spray administration technique. On September 20, 2024, the FDA announced the approval of FluMist for self- or caregiver-administration. A prescription is still required to receive FluMist Home. FluMist was initially approved by the FDA in 2003. The FDA issued STN: BL 125020/2606 on July 9, 2020, and BL 125020/2852 on July 27, 2022, and was approved for the 2024–2025 Influenza Season. On October 24, 2023, AstraZeneca announced that a Supplemental Biologics License Application (sBLA) for approving a self- or caregiver-administered option for FluMist has been accepted for review by the U.S. FDA. On August 6, 2024, the FDA issued STN: BL 125020/3070. 

"Today's approval of the first influenza vaccine for self- or caregiver administration provides a new option for receiving a safe and effective seasonal influenza vaccine, potentially with greater convenience, flexibility, and accessibility for individuals and families," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a press release. The FDA approved FluMist for MedImmune LLC. ATC code: J07BB03; CAS Number: 1704512-59-3.

On August 15, 2025, Flumist Home became available in the United States.

Delaware-based AstraZeneca (AZN) is a global, science-led biopharmaceutical company focusing on discovering, developing, and commercializing prescription medicines. Click here to find a FluMist location in the USA.

FluMist Indication

FluMist is FDA-approved for preventing influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. It is the first influenza vaccine that does not require administration by a healthcare provider.

Flumist Dosage

There are now two approved options for receiving FluMist. The vaccine may be administered by a healthcare provider in a healthcare setting (including a pharmacy) or by the vaccine recipient or a caregiver who is 18 years or older. FluMist is sprayed into the nose. Vaccine recipients and caregivers who administer FluMist will be sent the vaccine, the Prescribing Information, Information for Patients and their Caregivers, and Instructions for Use. Estimates show that as many as 2 in 3 children and 1 in 4 adults have intense fears around needles. 

FluMist Quadrivalent Side Effects

The most common side effects are a runny or stuffy nose, a sore throat, and a fever over 100°F. FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy. In clinical trials, the risk of hospitalization and wheezing was increased in children aged <24 months who received trivalent FluMist. In a study published by the AAP journal Pediatrics on March 25, 2022, LAIV4 was not associated with an increased frequency of asthma exacerbations, an increase in asthma-related symptoms, or a decrease in peak expiratory flow rate compared with IIV4 among children aged 5 to 17 years with asthma.

FluMist Vaccine Effectiveness

Since the 2018 flu season, the FLUMIST vaccine has demonstrated effectiveness comparable to that of other FDA-approved flu shots.

FluMist Home

In 2025, FluMist Home will utilize an online pharmacy. Although a prescription will still be required, the vaccine manufacturer plans to make FluMist accessible through a third-party online pharmacy for the 2025-2026 flu season. Caregivers aged 18 years or older are required to administer the vaccine to children. On April 15, 2025, AZ presented the updated FluMist Home launch plan to the U.S. CDC ACIP. More information is available at www.FluMist.com.

Fluenz® Tetra Influenza Vaccine

The LAIV has been used in the U.K. since 2013 to protect children against influenza infection. In the United Kingdom (U.K.), over 3 million students in secondary school years 7 to 11 will be offered the nasal spray vaccine through their school's vaccination program starting September 2023. On December 16, 2022, the U.K. The Health Security Agency confirmed that Fluenz Tetra offers protection for scarlet fever and group A strep infections in children.

FluMist Vaccine News

August 15, 2025 - Joris Silon, US Country President and Senior Vice President, AstraZeneca, said: "The launch of FluMist Home is a transformational moment in the evolution of influenza protection, bringing a simple and accessible option directly into the hands of consumers. FluMist Home reflects the growing importance of direct-to-consumer offerings and underscores our commitment to continuous innovation, making it easier for people to get vaccinated and stay protected."

September 20, 2024 - Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented, "Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health."

October 24, 2023 - AstraZeneca confirmed a Supplemental Biologics License Application for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT.

September 5, 2023 - AstraZeneca announced FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) doses were available in the U.S. for the 2023-2024 flu season.

February 28, 2023 - Japan health ministry panel endorses nasal flu vaccine for children.

November 10, 2022 - AstraZeneca confirmed Flumist vaccine revenues reached about 59 million year-to-date.

September 23, 2022 - AstraZeneca announces FLUMIST® QUADRIVALENT doses are available in the U.S. for the 2022-2023 influenza season. "Educating communities about flu safety measures and encouraging yearly flu vaccination remains an important part of reducing serious and contagious health threats," said Liz Bodin, Vice President, U.S. Respiratory & Immunology, AstraZeneca.

March 25, 2022 - The results from a limited (151 children) clinical trial published by the AAP suggest that within 42 days of vaccination, 10.8% of children who received the intranasal LAIV4 experienced an asthma exacerbation compared with 14.7% of those who received the intramuscular IIV4; risk difference -0.0390, 90% CI -0.1453 to 0.0674).

August 31, 2021 - AstraZeneca announced that FLUMIST® QUADRIVALENT vaccine doses are available in the U.S. for the 2021-2022 influenza season. FLUMIST QUADRIVALENT is the only U.S. FDA-Approved nasal-spray flu vaccine.

August 26, 2021 - The U.S. FDA confirmed that (3) FluMist Quadrivalent lots from MedImmune, LLC, were released. 

June 1, 2021 - Global Nasal Spray Vaccine Market 2020 Development Analysis – AstraZeneca FluMist, Cipla, BCHT

February 11, 2021 - AstraZeneca plc published financial results, which stated Flumist Total Revenue, entirely comprising Product Sales, increased by 161% in the year (153% at CER) to $295 m, reflecting the greater use of influenza vaccines as health authorities in northern-hemisphere countries expanded seasonal-vaccination programs beyond typical levels during the ongoing COVID-19 pandemic. In the U.S., sales increased by 254% in the year to $70m and, in Europe, by 135% (126% at CER) to $219m.

November 25, 2020 -  Israel ordered AstraZeneca's FluMist vaccines for its citizens.

August 13, 2020 - AstraZeneca Ships FLUMIST® QUADRIVALENT Vaccine in the U.S. for the 2020-2021 Flu Season. AstraZeneca has increased production of FluMist QUADRIVALENT doses in the U.S. by over 25% more than planned, most of which are expected to be available by the end of September.

FluMist Quadrivalent Clinical Trials

AstraZeneca's FluMist has been studied in several clinical trials.

0 min read
Manufacturer: 
AstraZeneca
Reviewer: 
Robert Carlson, MD
Vaccine: 
Flumist Influenza Vaccine
VIS: 
PDF
Availability: 
USA, UK, Canada, Japan
Generic: 
Flu Nasal Vaccine
Drug Class: 
Intranasal vaccine
Clinical Trial Phase I: 
A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
Clinical Trial Phase II: 
A Phase 2 Study to Evaluate Immune Responses of FluMist®
Clinical Trial Phase III: 
Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted
Clinical Trial Phase IV: 
Self-Administered Nasal Influenza Feasibility Study (SNIF)
Lab Test: 
CDC
Condition: 
Influenza
Availability Link: 
FluMist
Last Reviewed: 
Monday, December 15, 2025 - 09:50
Brand: 
FluMist®, Fluenz® Tetra
Abbreviation: 
LAIV
CPT Code: 
90672
ChemSpider ID: 
1704512-59-3
Accession Number: 
J07BB03
Status: 
Approved
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
Kosher: 
Yes
Side Effects: 
Warnings and Precautions
Ingredients: 
FluMist Ingredients
Countries: 
Canada
U.S.
U.K.
Japan
Cell Line Production: 
Chicken Eggs
Rate Vaccine: 
CgagJK7r
Location tags: 
Austin
New York
Florida
London

Fluarix Quadrivalent Influenza Vaccine

Fluarix Quadrivalent Vaccine 2023

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

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

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

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

Fluarix Quadrivalent Indication

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

Fluarix Quadrivalent Dosage

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

Fluarix Quadrivalent and COVID-19 Vaccines

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

Fluarix Quadrivalent Side Effects

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

Fluarix Quadrivalent News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Fluarix Quadrivalent Clinical Trials

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

0 min read
Manufacturer: 
GSK
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Fluarix Quadrivalent Influenza Vaccine
VIS: 
PDF
Availability: 
2023-2024
Drug Class: 
Vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
Quadrivalent Vaccine Pregnancy Registry
Clinical Trial Phase II: 
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
Clinical Trial Phase III: 
mmunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra
Lab Test: 
CDC
Condition: 
Influenza
Availability Link: 
40 million influenza vaccines for the 2023-2024 flu season
Last Reviewed: 
Wednesday, October 18, 2023 - 07:35
Brand: 
Fluarix
CPT Code: 
90686
Accession Number: 
DB15702
Status: 
Approved
Manufacturer Country ID: 
UK
Side Effects: 
FDA
Ingredients: 
FDA
Countries: 
USA
EU (Fluarix Tetra)
UNII: 
L7ZT1J7AEZ
Cell Line Production: 
Chicken Eggs
Rate Vaccine: 
v5y7ypID

Fluad Influenza Vaccine

Fluad® Influenza Vaccine Clinical Trials, Dosage, Indication, Side Effects

CSL Seqirus, Inc. Fluad® Influenza Vaccine (Fluad Tetra) consists of an inactivated influenza virus antigen produced in eggs and an oil-in-water emulsion adjuvant, MF59. Fluad is a U.S. FDA-approved seasonal flu shot containing an adjuvant, an immune-enhancing ingredient. Fluad is indicated for active immunization against influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Compared to Fluad, FLUAD QUADRIVALENT includes an additional B virus strain to help prevent disease caused by all four influenza strains in the vaccine.

The immune-enhancing ingredient in Fluad is an oil derived from squalene. Squalene is a naturally occurring substance in humans, animals, and plants. Adults aged 65 and older with an aging immune system might have a lower immune response to traditional flu vaccines than younger adults. Squalene, the immune-enhancing ingredient, provides a robust immune response to help adults' immune systems recognize and respond to the flu virus, says the U.S. Centers for Disease Control and Prevention (CDC). Fluad has an extensive clinical legacy, with millions of vaccine doses distributed and licensure in 30 countries since it was first approved in 1997.

On November 24, 2015, the U.S. FDA sent an approval letter authorizing Seqirus, Inc. to introduce and deliver Fluad into interstate commerce. STN: 125510. On March 30, 2021, the FDA issued a supplement Biologics License Application (STN: BL 125510/236) for Influenza Vaccine, Adjuvanted (FLUAD), manufactured at your Holly Springs, NC facility. STN: 125510 was published in July 2023. This adjuvanted inactivated influenza vaccine (IIV-Adj) is currently authorized in Canada and Europe under the Fluad Tetra brand: EMEA/H/C/004993. The U.S. CDC recognized FLUAD® as a preferentially recommended seasonal vaccine option for adults aged 65+. As of December 20, 2023, Canada's National Advisory Committee on Immunization preferentially recommended FLUAD® Influenza vaccine for adults 65 and older. Influenza activity in Canada for the previous year's flu seasons is posted at this link.

New Jersey-based CSL Seqirus (CSL.AX) is a leader in the fight against influenza with an innovative portfolio of influenza products. CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. On February 12, 2024, CSL Seqirus reported Fluad's revenues increased 14% during the last half year.

Fluad Quadrivalent Vaccine Price

Seqirus provides a coding and billing guide for healthcare providers. CMS.gov provides seasonal influenza pricing. For the 2022-2023 Flu season, the Fluad Quadrivalent payment allowance is $71.68.

Fluad Trivalent Vaccine Description

Fluad (aTIV) consists of an inactivated, trivalent influenza virus antigen produced in eggs and an oil-in-water emulsion adjuvant, MF59. Adding MF59  adjuvant to an influenza vaccine is designed to enhance the immune response to the influenza strains contained in the vaccine in adults 65 years and older. For 2021-2022, the FDA has recommended the trivalent (three-component) egg-based vaccine that includes these components. For the 2024-2025 flu season, the FDA has directed manufacturers to remove the B/Yamagata influenza virus strain from all influenza vaccines distributed in the U.S.

Fluad Vaccine Pediatric Description

Fluad Pediatric® contains 7.5 µg HA per strain administered as a 0.25 mL dose by IM injection for children 6-23 months of age and is currently authorized in Canada.

Fluad Vaccine Indication

The Fluad egg-based vaccine is indicated for active immunization against influenza viruses caused by influenza virus subtypes A and type B in the vaccine. Fluad helps protect against the same flu strains as other seasonal flu shots, but it has something they don't have: an immune-enhancing ingredient that can help immune response to the flu in adults 65 and older. Seniors with an aging immune system might have a lower immune response to traditional flu vaccines than younger adults.

Fluad Vaccine Dosage

Fluad is administered as an intramuscular injection.

Fluad Vaccine Adverse Events

Some adverse events (reported after regular flu vaccines) were reported more frequently after vaccination with FLUAD. During clinical studies, the adverse events were mild to moderate and temporary: pain, redness at the injection site, headache, muscle aches, and malaise. People should not get FLUAD or FLUAD QUADRIVALENT if they have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine.

Fluad Vaccine News

August 16, 2024 - A study demonstrated comparable effectiveness of aTIV and HD-TIV among individuals with no identified risk factors and higher effectiveness of aTIV compared with HD-TIV in preventing any IRMEs, outpatient IRMEs, and influenza- or pneumonia-related hospitalizations among those with at least one or multiple high-risk factors in adults ≥65 years old.

December 21, 2023 - "The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems," said Bertrand Roy, Ph.D., Country Head of Medical Affairs Canada at CSL Seqirus. "We are pleased that NACI's thorough review and recommendation will help immunizers optimize the delivery of annual influenza immunizations to help mitigate other potentially difficult flu seasons."

July 17, 2023 - CSL Seqirus stated it is the only manufacturer to offer differentiated influenza vaccine options approved for use in individuals six months of age and older for the 2023/24 U.S. influenza season.

September 26, 2022—Seqirus announced real-world evidence showing that adults 65 years of age and older had fewer influenza-related hospitalizations during the 2019/20 U.S. influenza season when vaccinated with FLUAD® (Influenza Vaccine, Adjuvanted), an MF59®-adjuvanted trivalent vaccine (aTIV), compared to quadrivalent inactivated influenza vaccine (QIVe) or a high-dose trivalent vaccine (HD-TIV).

June 22, 2022 - The CDC ACIP committee recommends adults 65 years of age and older receive an enhanced flu vaccine, such as FLUAD® QUADRIVALENT, to help protect against four seasonal influenza strains annually.

March 4, 2022 - Gregg Sylvester, Chief Medical Officer, Seqirus. "According to the CDC, older adults have an increased risk of influenza-related complications and severe outcomes. Data from the recent ACIP systematic review support the benefit of an Enhanced Influenza Vaccine for this population. Seqirus is proud to support the public health benefit that an EIV category recommendation for older adults would provide."

April 20, 2021 - Real-World-Evidence published in the journal Clinical Infectious Diseases indicates that Seqirus' aTIV was more effective in reducing influenza-related medical encounters compared with standard egg-based quadrivalent influenza vaccine (QIVe) and high-dose trivalent influenza vaccine (TIV-HD) among adults 65 years and older during the 2017/18 and 2018/19 U.S. influenza seasons.

December 14, 2020 - Seqirus Presents New Late-Breaking Data at ESWI 2020, Highlighting Benefits of MF59®-Adjuvanted Seasonal Influenza Vaccine. "Adults age 65 years and older are at higher risk for complications from seasonal influenza.

September 21, 2020 - Seqirus announced the publication of new real-world evidence (RWE) that demonstrated an MF59® adjuvanted, trivalent influenza vaccine (aTIV) was more effective than a standard-dose non-adjuvanted trivalent seasonal vaccine in preventing influenza-related medical office visits and hospitalizations in adults 65 years and older during the 2017/18 U.S. influenza season.

February 24, 2020 - Seqirus Receives U.S. FDA Approval for FLUAD QUADRIVALENT for Adults 65 Years and Older.

Fluad Clinical Trials

Seqirus continues participating in clinical trials for its family of Fluad influenza vaccines.

0 min read
Manufacturer: 
Seqirus
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Fluad Influenza Vaccine
VIS: 
PDF
Availability: 
Various countries
Generic: 
aTIV
Clinical Trial: 
https://flu.seqirus.com/Formulation/Fluad/p/FluadIn?seasonCategoryCode=Seqirus_InSeason
Drug Class: 
Vaccine, Adjuvanted
Find Price: 
Discounts
Clinical Trial Phase II: 
Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 20
Clinical Trial Phase III: 
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects
Clinical Trial Phase IV: 
FLUAD® vs. Fluzone® High-Dose Study
Lab Test: 
Influenza Tests
Condition: 
Influenza
Availability Link: 
Canada
Last Reviewed: 
Tuesday, August 20, 2024 - 06:15
Brand: 
Fluad, Fluad Tetra
CPT Code: 
90694
Accession Number: 
DB15788
Status: 
Approved
Manufacturer Country ID: 
US
FDA First In Class: 
Yes
Kosher: 
Yes
Halal: 
Yes
Side Effects: 
Warnings and Precautions
Ingredients: 
FDA Insert
Countries: 
USA
UK
Canada
EU (Fluad Tetra)
Brazil
Spain (Chiromas)
Australia
Mexico
New Zealand
UNII: 
G1T4TD4PZC
Cell Line Production: 
Chicken Eggs
Rate Vaccine: 
k7a5JhDG

Flu-v Influenza Vaccine

Flu-v Influenza Description 2022

FLU-v is a novel peptide vaccine candidate.

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

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

Flu-v Indication

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

Flu-v Dosage

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

Flu-v News 2010 - 2022

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

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

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

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

Flu-v Clinical Trials

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

0 min read
Manufacturer: 
SEEK formally PepTCell Ltd
Reviewer: 
Robert Carlson, MD
Holly Lutmer PharmD
Vaccine: 
Flu-v Influenza Vaccine
Generic: 
Flu shot
Drug Class: 
Peptide Vaccine
Clinical Trial Phase I: 
Influenza Challenge Study in Healthy Volunteers
Clinical Trial Phase II: 
Efficacy of FLU-v in an H1N1 Influenza Human Challenge Model
Condition: 
Influenza
Last Reviewed: 
Sunday, June 5, 2022 - 08:50
Brand: 
Flu-V
Status: 
Candidate
Manufacturer Country ID: 
UK

Engerix-B Hepatitis B Vaccine

Engerix-B Vaccine Description 2022

Engerix-B is a noninfectious recombinant DNA hepatitis B vaccine. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus.

Engerix-B (Hep-B) is a noninfectious recombinant DNA vaccine containing hepatitis B surface antigen (HBsAg). It is produced from genetically engineered yeast (Saccharomyces cerevisiae). Intramuscular Hep-B [0-, 1-, 6-month schedule] has excellent immunogenicity in healthy neonates and infants, children, adolescents, and adults, with seroprotection rates of 85-100% seen approximate, equals 1 month after the final dose of vaccine; seroprotection was defined as an antibody against HBsAg (anti-HBs) titre of > or =10 IU/L. 

Engerix-B is a trademark of the GlaxoSmithKline group of companies.

Engerix-B Vaccine Indication

Engerix-B is a vaccine for immunization against infection caused by all known subtypes of the hepatitis B virus. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by ENGERIX-B vaccination.

Engerix-B Vaccine Dosage

Engerix-B is administered as an intramuscular injection for persons aged 20 years and older consisting of a series of 3 doses given on a 0-, 1-, and 6-month schedule.

Primary immunization for infants (born of hepatitis B surface antigen [HBsAg]-negative or HBsAg-positive mothers), children (birth through 10 years), and adolescents (aged 11 through 19 years) consist of a series of 3 doses given on a 0-, 1-, and 6-month schedule.

Engerix-B Clinical Trials

GSK's Engerix-B has been studied in over 60 clinical trials.

0 min read
Manufacturer: 
GSK
Reviewer: 
Robert Carlson, MD
Vaccine: 
Engerix-B Hepatitis B Vaccine
VIS: 
PDF
Availability: 
U.S. FDA authorized
Generic: 
Hep B Vaccine
Drug Class: 
Recombinant DNA Vaccine
Find Price: 
Discounts
Clinical Trial Phase I: 
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Clinical Trial Phase II: 
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
Clinical Trial Phase III: 
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Clinical Trial Phase IV: 
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Lab Test: 
CDC
Condition: 
Hepatitis B
Last Reviewed: 
Monday, March 14, 2022 - 14:15
Brand: 
Engerix-B
CPT Code: 
90744
Accession Number: 
DB11627
Status: 
Approved
Manufacturer Country ID: 
US
Side Effects: 
Adverse Reactions
Ingredients: 
Description
Countries: 
USA
UNII: 
IFJ010MNE4
Rate Vaccine: 
KTYAsBuM

Dengvaxia Dengue Vaccine

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.

    0 min read
    Manufacturer: 
    Sanofi Pasteur, Ltd.
    Reviewer: 
    Robert Carlson, MD
    Vaccine: 
    Dengvaxia Dengue Vaccine
    VIS: 
    PDF
    Availability: 
    Limited availability in Asia, Brazil, Caribbean Islands, Europe, the Americas
    Generic: 
    CYD-TDV
    Clinical Trial: 
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325986/
    Drug Class: 
    Live attenuated tetravalent chimeric vaccine
    Find Price: 
    Discounts
    Clinical Trial Phase II: 
    Efficacy and Safety of Dengue Vaccine in Healthy Children
    Clinical Trial Phase III: 
    Phase 3 Trial Results of Dengue Vaccine Candidate in Asia
    Clinical Trial Phase IV: 
    Assessing the Effectiveness of Sanofi Pasteur's Dengue Vaccine (Dengvaxia) Against Hospitalization and Symptomatic Infection in
    Lab Test: 
    CDC
    Condition: 
    Dengue
    Availability Link: 
    Sanofi
    Last Reviewed: 
    Wednesday, October 1, 2025 - 06:45
    Brand: 
    Dengvaxia
    CPT Code: 
    90717
    Accession Number: 
    DB15522
    Status: 
    Approved
    Manufacturer Country ID: 
    FR
    FDA First In Class: 
    Yes
    Kosher: 
    Yes
    Halal: 
    Yes
    Side Effects: 
    Warnings and Precautions
    Ingredients: 
    Description of Ingredients
    Countries: 
    USA - Puerto Rico
    WHO
    Brazil
    Mexico
    El Salvador
    Singapore
    French Polynesia
    Reunion Island
    Costa Rica
    Puerto Rico
    Philippines
    The Americas
    India - pending
    Guam
    Columbia
    Florida
    Costa Rica
    UNII: 
    FH5SVG7GLC
    Cell Line Production: 
    Vero Cell Lines
    Rate Vaccine: 
    HUQ2SZgb
    Location tags: 
    Puerto Rico

    Daptacel Vaccine

    Daptacel Vaccine

    Daptacel is a combination pediatric vaccine that helps prevent diphtheria, tetanus, and pertussis. It is a five-dose series for infants and children from 6 weeks to 6 years of age. Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

    Daptacel contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, and acellular pertussis antigens [10 µg detoxified pertussis toxin (PT), 5 µg filamentous hemagglutinin (FHA), 3 µg pertactin, and 5 µg fimbriae types 2 and 3 (FIM)] in each 0.5-mL dose. Other ingredients per 0.5-mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤5 µg residual formaldehyde, <50 nanognanograms residual glutaraldehyde and 3.3 mg [0.6% volume per volume (v/v)] 2-phenoxyethanol (not as a preservative).

    Daptacel Vaccine Indication

    Daptacel is indicated for active immunization against diphtheria, tetanus, and pertussis as a five-dose series in infants and children six weeks through 6 years of age (before birthdays). 

    Daptacel Vaccine Dosage

    Daptacel is administered as an intramuscular injection, as a five-dose series at 2, 4, and 6 months of age (at intervals of 6-8 weeks), 15-20 months, and 4-6 years. The first dose may be given as early as six weeks of age. Four doses of Daptacel constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of Daptacel constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization. 

    Daptacel Vaccine News

    October 18, 2021 - A report published by The Lancet Infectious Diseases discusses the importance of pertussis vaccinations for infants. Infants are very vulnerable to pertussis infections and are at high risk of severe outcomes until they can be vaccinated at two months of age. It is very important for their well-being that those around them indirectly protect them 16, 2020 - A report published by Fior Markets, the global diphtheria, pertussis, and tetanus (DTaP) vaccine market is expected to grow from USD 2.97 Billion in 2018 to USD 5.07 Billion by 2026, at a CAGR of 6.91% during the forecast period from 2019-2026. This forecast is based on the growing number of diphtheria, tetanus, and pertussis cases, as well as worldwide governmental vaccine programs.  

    Daptacel Vaccine Clinical Trials

    DaptacThe el Vaccine has been involved in hundreds of clinical trials. 

    0 min read
    Manufacturer: 
    Sanofi Pasteur, Ltd.
    Reviewer: 
    Robert Carlson, MD
    Holly Lutmer PharmD
    Vaccine: 
    Daptacel Vaccine
    VIS: 
    PDF
    Generic: 
    Dtap (diphtheria, tetanus, and pertussis)
    Drug Class: 
    Vaccine
    Find Price: 
    Discounts
    Clinical Trial Phase III: 
    Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel or DAPTACEL
    Condition: 
    Childhood Diseases
    Last Reviewed: 
    Wednesday, June 19, 2024 - 05:30
    Brand: 
    Daptacel
    CPT Code: 
    90700
    Accession Number: 
    DB10789
    Status: 
    Approved
    Side Effects: 
    Daptacel
    UNII: 
    63GD90PP8X