Sanofi Says Good Results From Flu Vaccine With Mrna Booster Study
A Sanofi logo is seen during the company’s annual results news conference in Paris, France, February 6, 2020. REUTERS/Benoit Tessier
PARIS, Oct 7 – French healthcare company Sanofi said on Wednesday that it had found positive results from the first study into a high-dose influenza vaccine with a COVID-19 mRNA booster.
Sanofi said the interim results from the study of Sanofi’s Fluzone High-Dose Quadrivalent vaccine with Moderna’s COVID-19 mRNA investigational booster dose showed the vaccines had similar immunogenicity responses and a similar safety and tolerability profile.
“These positive results could facilitate the implementation of Northern Hemisphere influenza and COVID-19 booster vaccination campaigns, especially in this high-risk population,” said Dr. Michael Greenberg, North America Medical Head for Vaccines at Sanofi.
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How Safe Is Fluzone High
Some side effects were reported more frequently after vaccination with trivalent Fluzone High-Dose than after standard-dose inactivated flu vaccines. The most common side effects experienced during clinical studies were mild and temporary, and included pain, redness at the injection site, headache, muscle aches, and malaise. Most people had minimal or no side effects after receiving the Fluzone High-Dose. In a study comparing Fluzone High-Dose Quadrivalent with trivalent Fluzone High-Dose, some of these side effects were slightly more common with the quadrivalent vaccine, but most were mild and resolved within a few days.
Table 1 Influenza Vaccines United States 202021 Influenza Season*
|Trade name||HA or virus count for each vaccine virus||Route|
|Standard dose, cell culture based|
|High dose, egg based|
|Fluzone High-Dose Quadrivalent|
|Standard dose, egg based with MF59 adjuvant|
|Standard dose, egg based with MF59 adjuvant|
|0.2-mL prefilled single-use intranasal sprayer||2 through 49 yrs||106.5-7.5 fluorescent focus units/0.2 mL||NAS|
Abbreviations: ACIP = Advisory Committee on Immunization Practices FDA = Food and Drug Administration HA = hemagglutinin IIV3 = inactivated influenza vaccine, trivalent IIV4 = inactivated influenza vaccine, quadrivalent IM = intramuscular LAIV4 = live attenuated influenza vaccine, quadrivalent MDV = multidose vial NAS = intranasal PFS = prefilled syringe RIV4 = recombinant influenza vaccine, quadrivalent SDV = single-dose vial.
* Vaccination providers should consult FDA-approved prescribing information for 202021 influenza vaccines for the most complete and updated information, including indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccinesexternal icon. Availability and characteristics of specific products and presentations might change and/or differ from what is described in this table and in the text of the full report.
§ The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years.
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Sanofi Reports Positive Data From Study Of Flu Shot With Covid Booster
The study evaluated the safety and immunogenicity of a 100µg dose of a Covid-19 booster given along with the influenza vaccine.
Sanofi has reported positive interim data from a descriptive study of its Fluzone High-Dose Quadrivalent vaccine with Modernas experimental Covid-19 booster vaccine.
Findings showed that administering the vaccines at the same time offered immunogenicity responses and a safety and tolerability profile in line with those observed when they are given separately.
An influenza vaccine, Fluzone High-Dose Quadrivalent is approved for use in adults aged 65 and above in the US and Canada.
It is licenced as Efluelda in Europe for use in adults aged 60 and above.
Funded by Sanofi, the study is being conducted in the US in collaboration with Moderna and the US Biomedical Advanced Research and Development Authority .
The study is currently following up the subjects for six months for safety.
It comprised nearly 300 subjects aged 65 years and above who were already inoculated with two doses of Modernas vaccine as the primary vaccination a minimum of five months before recruitment.
The study analysed the safety and immunogenicity of 100µg dose of Covid-19 booster shot administered with the influenza vaccine in these subjects.
These positive results could facilitate the implementation of Northern Hemisphere influenza and Covid-19 booster vaccination campaigns, especially in this high-risk population.
Fluzone Influenza Vaccine Indication
Fluzone Quadrivalent and Fluzone High-Dose vaccines help prevent influenza disease caused by influenza A and B strains contained in each vaccine.
Fluzone Quadrivalent is approved to help protect eligible people 6 months and older. Fluzone High-Dose is specifically formulated for people 65 years and older, containing 4 times the standard dose. Its proven to be 24.2% more effective than the standard-dose Fluzone vaccine in preventing the flu.
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Fluzone Influenza Vaccine Safety Information
Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any vaccine component or after a previous dose of the vaccine. In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.
Influenza Vaccine With Covid
Posted: 12 October 2021 | Anna Begley |
Sanofis Fluzone® with Modernas COVID-19 mRNA investigational booster dose showed an immunogenicity response similar to individual doses.
Sanofi has announced positive data from the first study of their high-dose influenza vaccine with a COVID-19 messenger RNA booster shot. Interim results from the first co-administration descriptive study of Sanofis Fluzone® High-Dose Quadrivalent vaccine with Modernas COVID-19 mRNA investigational booster dose show that the administration of the vaccines at the same visit had similar immunogenicity responses and a similar safety and tolerability profile compared to each vaccine administered individually.
Fluzone® High-Dose Quadrivalent is a high-dose quadrivalent influenza vaccine, indicated for adults aged 65 and older in the United States and Canada. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. According to Sanofi, Fluzone High-Dose is the only influenza vaccine that has demonstrated reductions in influenza-related complications such as hospitalisations due to cardiovascular events and pneumonia, over 10 consecutive seasons in more than 34 million people aged 65 and older.
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Table Influenza Vaccines United States 202122 Influenza Season*
|µg HA or virus count for each vaccine virus||Route|
|0.2-mL prefilled single-use intranasal sprayer||2 through 49 yrs||
106.57.5 fluorescent focus units/0.2 mL
Abbreviations: ACIP = Advisory Committee on Immunization Practices FDA = Food and Drug Administration HA = hemagglutinin IIV4 = inactivated influenza vaccine, quadrivalent IM = intramuscular LAIV4 = live attenuated influenza vaccine, quadrivalent MDV = multidose vial mos = months NAS = intranasal PFS = prefilled syringe RIV4 = recombinant influenza vaccine, quadrivalent SDV = single-dose vial
* Vaccination providers should consult FDA-approved prescribing information for 202122 influenza vaccines for the most complete and updated information, including indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at . Availability and characteristics of specific products and presentations might change or differ from what is described in this table and in the text of this report.
§The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged 3 years.
Fluzone Influenza Vaccine News
– The 2021-22 influenza season report for week 41 indicated the ILINet continues to report below baseline cases. Of 28,629 specimens tested, 36 were positive, 17 were influenza A, while 19 were influenza B.
– In the UK indicators for influenza such as hospital admissions and GP influenza-like illness consultation rates remain very low. Week 40 reported 8 influenza positive cases.
– Influenza virus circulation remains low therefore, increases in ILI activity are likely due to increased circulation of other respiratory viruses.
– The US CDC reported three regions are ar or above their ILI region-specific baselines, and the remaining regions are below their region-specific baselines.
– The U.S. Food and Drug Administration Center for Biologics Evaluation and Research has approved Sanofi Pasteur, the vaccines global business unit of Sanofi, for an additional influenza manufacturing facility located in Swiftwater, PA.
– Certain patients have an increased risk of influenza infections and poor serologic response to standard influenza vaccination. A new study found tandem high-dose influenza vaccination leads to more robust and more durable seroprotection in high-risk patients.
– High-dose flu vaccine is in short supply in some places. If the high-dose vaccine is not available, the CDC recommends getting the regular dose.
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Sanofi Trial Shows Fluzone High
PARIS – Sanofi said on Monday that a largeclinical trial showed its Fluzone High-Dose vaccine to be moreeffective at preventing influenza in adults aged 65 and olderthan a standard dose of Fluzone.
In the study, which included roughly 30,000 participants,Fluzone High-Dose vaccine was 24.2% more effective in preventinginfluenza in adults 65 years of age and older than Fluzonevaccine.
Fluzone High-Dose vaccine was licensed for sale by the FDAin 2009 under an accelerated approval process that included arequirement that Sanofi complete a large-scale confirmatorystudy.
Sanofi said it plans to submit the full clinical studyreport to the U.S. Food and Drug Administration for review byearly 2014 and will seek to modify to the label for FluzoneHigh-Dose vaccine to reflect the superior efficacy data in thisage group.
Fluzone Influenza Vaccine Descriptions
Sanofi Pasteur’s Fluzone Quadrivalent influenza vaccine contains the 2 strains each of influenza A and B identified for the current flu season. The Fluzone vaccine is given to people 6 months of age and older.
And the Fluzone High-Dose is a vaccine given to people 65 years of age and older that also contains 4 killed flu virus strains. Fluzone High-Dose contains four times the antigen of standard-dose inactivated influenza vaccines. The higher dose of antigen in the vaccine is intended to give older people a better immune response and better protection against flu, says Sanofi.
For the 2021-2022 flu season in the Northern Hemisphere, the quadrivalent egg-based vaccines protect against a second lineage of B viruses. U.S. Egg-Based influenza vaccines are recommended to contain the following A/Victoria/2570/2019 pdm09-like virus, A/Cambodia/e0826360/2020 -like virus, B/Washington/02/2019 -like virus, and B/Phuket/3073/2013 -like virus.
Sanofi Pasteur produces influenza vaccines each year across five international sites: Swiftwater , Pearl River , Val-de-Reuil, Ocoyoacac , and Shenzhen . As the largest manufacturer of influenza vaccines globally, Sanofi has been continuously investing to expand manufacturing capabilities and distributed more than 250 million doses of influenza vaccines globally in 2020.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.|
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Sanofi Pasteur Said In A Statement
In recent days, the Ministry of Health had also approved the concomitant administration of the two serums in the same session.
The quadrivalent high-dose influenza vaccine is indicated in adults aged 60 and over in Italy.
It is the only influenza vaccine that has demonstrated superior efficacy in preventing laboratory-confirmed influenza disease and reducing influenza-associated complications, such as hospitalisations for cardiovascular events and pneumonia, for 10 consecutive seasons in more than 34 million people.
The encouraging results of the co-administration study reinforce the recommendations for the simultaneous administration of the two vaccines also in Italy, the note continues.
This study says Francesca Trippi, Medical Head of Sanofi Pasteur shows how in an unprecedented historical period like the one we are living, still marked by the health emergency of the pandemic and with the new flu season just around the corner, we need timely, rapid and concrete answers on the optimal and effective management of vaccination campaigns.
This is the first study to produce positive scientific evidence in terms of antibody responses and safety profile, supporting the concomitant administration of high-dose influenza vaccine with the third dose of anti-Covid19 vaccine.
These results point in the direction of facilitating the conduct of vaccination campaigns to ensure optimal protection for the high-risk population.
Sanofi To Build New Facility In Canada To Increase Global Availability Of High
Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine
- Sanofi announces investment of more than 600 million to build a new vaccine facility in Toronto to increase supply of its differentiated influenza vaccines in Canada, the United States and Europe
- In partnership with the Governments of Canada and Ontario, and the City of Toronto, the new facility will also enhance influenza pandemic preparedness efforts
- Fluzone® High-Dose Quadrivalent influenza vaccine has four times more antigen than standard-dose vaccine and is specifically designed to provide superior protection against influenza for older adultsi
PARIS March 31, 2021 Sanofi today announced an investment of more than 600 million in a new vaccine manufacturing facility at its existing site in Toronto, Canada. The investment in a new facility will provide additional antigen and filling capacity for Sanofis Fluzone® High-Dose Quadrivalent influenza vaccine, helping to increase supply availability in Canada, the United States and Europe.
Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment.
Editors Note: This investment in a new vaccine manufacturing facility further demonstrates Sanofis overall growth strategy, with vaccines contributing as a key growth driver through differentiated products, market expansion and new launches.
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What Is The Difference Between Fluzone High
Fluzone High-Dose Quadrivalent contains four times the antigen, the part of the vaccine that helps your body build up protection against flu viruses, than Fluzone Quadrivalent and other standard-dose inactivated flu vaccines. The higher dose of antigen in the vaccine is intended to give people 65 years and older a better immune response to vaccination, and therefore, better protection against flu. Both Fluzone High-Dose and Fluzone Quadrivalent are produced by the same manufacturer and are quadrivalent vaccines. There are a number of other flu vaccines produced by other manufacturers.
Why Is There A Need For Flu Vaccines Designed Specifically For People 65 Years And Older
People 65 years and older are at increased risk of developing serious complications from flu compared with young, healthy adults. This is partly because human immune defenses become weaker with increasing age. During most seasons, people 65 years and older account for the majority of flu hospitalizations and deaths. In the United States, between about 70 percent and 85 percent of seasonal flu-related deaths and between 50 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people 65 years and older. The weakened immune system can also mean that older people dont respond as well to flu vaccination. Given the higher risk of severe flu illness and lower protective immune response after vaccination among older adults, substantial research and development have led to the production of new flu vaccines intended to provide better immunity in this age group.
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Fluzone Influenza Vaccine Side Effects
Fluzone vaccines are generally well-tolerated, however, 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, meaning it relies on individuals to send in reports of their experiences to a vaccine. Anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS.
Sanofi: Positive Results From The First Study Of High
Positive results from the first study of high-dose influenza vaccine with a COVID-19 mRNA booster support co-administration recommendations
- First study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
- Timely new data for the start of the influenza vaccination campaigns across the Northern Hemisphere
7 October 2021
Interim results from the first co-administration descriptive study of Sanofis Fluzone® High-Dose Quadrivalent vaccine with Modernas COVID-19 mRNA investigational booster dose show that the administration of the vaccines at the same visit had similar immunogenicity responses and a similar safety and tolerability profile compared to each vaccine administered individually.
Fluzone® High-Dose Quadrivalent is a high-dose quadrivalent influenza vaccine, indicated for adults aged 65 and older in the United States and Canada. It is also licensed under the brand name Efluelda® in Europe where it is indicated for adults aged 60 and older. Fluzone High-Dose is the only influenza vaccine that has demonstrated reductions in influenza-related complications such as hospitalizations due to cardiovascular events and pneumonia, over 10 consecutive seasons in more than 34 million people aged 65 and older1,2,3.
About the study
About Fluzone® High-Dose Quadrivalent/ Efluelda®
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Seasonal Influenza Vaccines Pricing
The Medicare Part B payment allowance limits for seasonal influenza vaccines are 95% of the Average Wholesale Price , as reflected in the published compendia.
In hospital outpatient departments, payment is based on reasonable cost.
Annual Part B deductible and coinsurance amounts dont apply for the influenza virus vaccinations. All physicians, non-physician practitioners, and suppliers who administer these vaccinations must take assignment on the claim for the vaccine.
Annual Influenza Vaccine season starts on August 1 and ends on July 31 of the following year.