Gsk High Dose Flu Vaccine

How Can I Help Protect Myself

According to the CDC, the single best way to protect against the flu is for everyone 6 months of age and older to get vaccinated annually.1

Other everyday preventive actions to stop the spread of flu include:4

• Washing your hands with soap and water
• Covering your nose and mouth with a tissue when you cough or sneeze
• Staying home if you are feeling sick

In his own words

Ive always been a passionate advocate for vaccination throughout my career, even before coming to GSK as a vaccine research scientist. Flu vaccines are one of the most widely available vaccines whether you receive it from your doctor, your local pharmacy, or employer.

Dr. Leondard Friedland

VP, Director of Scientific Affairs and Public Health Vaccines, North America

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Issued: London, UK and Paris, France

• Agreements relate to vaccine candidate using Sanofis recombinant protein-based technology and GSKs pandemic adjuvant
• Both companies are committed to making their COVID-19 vaccine affordable and available globally

Sanofi and GSK have today signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021.

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said: Todays announcement showcases our unwavering commitment to develop a COVID-19 vaccine that is available to everyone when it comes to market. To address a global health crisis of this magnitude, it takes partnerships and we are grateful to Canada for their collaboration, and to GSK for partnering with us to develop a safe and effective vaccine.

Roger Connor, President of GSK Vaccines said:”GSK is proud to be working in partnership with Sanofi to make this vaccine available as soon as possible in Canada. Both companies have significant R& D and manufacturing capability world-wide and are already working hard to scale up production. This announcement from the Government of Canada supports our ongoing efforts.

Sanofi and GSK are committed to making the COVID-19 vaccine available globally

On 18th September Sanofi and GSK signed a final agreement with the European Commission to supply European countries with up to 300 million doses from their European industrial networks.

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Fda Approves Glaxosmithklines Four

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration has approved FLUARIX® QUADRIVALENT for the immunisation of children and adults to help prevent disease caused by seasonal influenza virus subtypes A and type B contained in the vaccine.

Issued Monday 17 December 2012, London UK

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration has approved FLUARIX® QUADRIVALENT for the immunisation of children and adults to help prevent disease caused by seasonal influenza virus subtypes A and type B contained in the vaccine. Fluarix Quadrivalent is the first intramuscular vaccine to cover against four influenza strains.

Scientists classify the influenza strains that cause seasonal flu as A or B strains. Currently administered trivalent flu vaccines help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year. But since the year 2000, two B virus strains have co-circulated to varying degrees each season. Various degrees of mismatch have occurred between the B strain included in trivalent vaccines and the B strain that actually circulated, causing an increased risk of influenza-related morbidity across all age groups children, adults and the elderly. Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a second B strain.

About Seasonal Influenza

About GlaxoSmithKline Vaccines

Canada Announces Deal For Millions Of Flu Vaccine Doses

Ottawa has signed a deal with the vaccine and specialty medicine manufacturing company GlaxoSmithKline to produce millions of additional influenza vaccines to better prepare for flu cases in the fall.

Federal Health Minister Jean-Yves Duclos made the announcement Friday, saying the procurement deal will ensure there are enough domestically produced influenza vaccines to meet Canadas needs during the upcoming flu season.

With first deliveries set for this fall, the deal will provide at least four million doses annually for government flu vaccine programs, with the option of procuring 80 million doses if an influenza pandemic occurs.

If there is one lesson to be learned from the pandemic, it is the critical importance of vaccination, Duclos said during the announcement at GSKs manufacturing site in Quebec City.

Duclos said the new agreement with GSK will allow Canada to ensure theres a consistent supply of flu vaccines produced in Canada and guard against supply chain disruptions.

By having national production here in Canada, we can ensure Canadas supply is not put at risk by border closures, trade disruptions, transportation problems, or shipping delays, Duclos said in French.

As COVID-19 will still be around in the fall when influenza cases are likely to return in greater numbers, the health minister stressed the importance of a robust flu vaccination plan as Canadas health-care system is already stretched thin.

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Flulaval Quadrivalent News 2016

May 4, 2022 – Flu News Europe announced for week 16, of 39 countries and areas reporting on the intensity of influenza activity, 18 reported baseline intensity , 14 reported low-intensity , 6 reported medium-intensity , and 1 reported high-intensity .

– The CDC FluView report indicated that Influenza activity increased nationally this week. Influenza activity is highest in the central and south-central regions of the country and is increasing in the northeastern regions.

– Despite increased influenza testing, levels continue to remain low, reported the WHO.

– The US CDC reported in week 41, that 0.1% of long-term care facilities reported > 1 influenza-positive test among residents. And no jurisdictions reported high or very high ILI activity.

– During week 40, the UK reported 8 influenza-positive cases.

– Nationwide during week 36, 2.3% of patient visits reported through ILINet were due to ILI. The percentage of patient visits for ILI remains below the baseline of 2.6% nationally.

– According to the US CDC, the percentages of visits for ILI reported in ILINet have been stable or decreasing among adult age groups and maybe starting to stabilize among the younger age groups .

– The U.S. FDA confirmed lots for FluLaval Quadrivalent from ID Biomedical Corporation of Quebec have been released and available for distribution in the USA.

Pandemic 2009 Influenza Update: Experience Of Gsks H1n1 Adjuvanted Vaccine Pandemrix And Preliminary Paediatric Results

GlaxoSmithKline today announced that, to date, more than 150,000 people have received GSK’s pandemic H1N1 vaccine, Pandemrix, as part of Government initiated vaccination programmes across Europe which commenced last week. Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing.

Issued: 23 October 2009, London UK

GlaxoSmithKline today announced that, to date, more than 150,000 people have received GSK’s pandemic H1N1 vaccine, Pandemrix, as part of Government initiated vaccination programmes across Europe which commenced last week. Additionally, over 2,000 people have received Pandemrix in clinical trials which are ongoing.

To date, data have demonstrated that the H1N1 adjuvanted vaccine has a similar tolerability profile to GSKs previously EMEA approved H5N1 adjuvanted vaccine. The immune response elicited by Pandemrix has previously been reported in a limited number of adults demonstrating over 98% of the subjects exceeded the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. The adjuvant system in GSKs influenza vaccine has already been tested in more than 41,000 people in GSKs influenza programmes including the H5N1, the H1N1 and candidate adjuvanted seasonal flu vaccines.

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Table Influenza Vaccines United States 202122 Influenza Season*

Influenza vaccines United States, 202122 influenza season*

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.

Sanofi : Fda Approves Fluzone High

FDA approves Fluzone® High-Dose Quadrivalent for adults 65 years of age and older

*Will be available in fall 2020, in time for the 2020-2021 flu season

PARIS – 4, 2019 The U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent for use in adults 65 years of age and older.

Fluzone® High-Dose was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.

Influenza is a serious threat, especially for older adults who are more vulnerable to serious complications and even death. For the past 10 years, Fluzone High-Dose has helped protect millions of people 65 years of age and older from seasonal influenza,said John Shiver, PhD, Senior Vice President, Global Research and Development, Sanofi Pasteur.We are committed to helping protect as many people as possible from influenza and look forward to introducing this new formulation.

i Fluzone High-Dose Quadrivalent . Swiftwater, PA: Sanofi Pasteur Inc.

ii Sanofi Pasteur Inc. Data on file .

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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.

Children Aged 3 Through 17 Years

FLUARIX QUADRIVALENT exhibited immunogenicity non-inferior to two trivalent inactivated influenza vaccines in a randomized, double-blind, active-controlled, safety, immunogenicity, and non-inferiority clinical trial.1

• Non-inferiority was based on adjusted GMTs and seroconversion rates
• Seroconversion was defined as a pre-vaccination hemagglutination-inhibition titer of < 1:10 with a post-vaccination titer 1:40 or at least a 4-fold increase in serum HI titer over baseline to 1:401

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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.

Percentage Of Patients With Solicitedlocal Adverse Reactions Within 7 Daysaafter First Vaccination In Childrenaged 6 Through 35 Monthsb1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 7: NCT01439360.
• cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine .
• dChildren 12 months and older: HAVRIX for those with a history of influenza vaccination or HAVRIX and a varicella vaccine for those with no history of influenza vaccination.
• eGrade 3 pain: Defined as cried when limb was moved/spontaneously painful. Grade 3 swelling, redness: Defined as > 50 mm.

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Pharmacy Administered Publicly Funded Vaccines And Testing Program Publicly Funded Seasonal Influenza Vaccine

For the 2021-2022 influenza season, the Department of Health will be offering a Universal Seasonal Influenza Program at no cost to New Brunswick residents. Pharmacists who have completed training and have been authorized by the New Brunswick College of Pharmacists to administer injections may administer the publicly funded seasonal influenza vaccine to those 2 years of age and older.

Vaccines must be administered by an authorized pharmacist.

The Pharmacist may employ a registered nurse, licensed practical nurse, pharmacy technician or paramedic to administer the publicly funded seasonal influenza vaccine however, the following conditions must be met:

Licensed pharmacists, who are certified for immunization, can provide vaccine to all New Brunswick residents with the exception of children under 2 years of age. Registered nurses, physicians, nurse practitioners, licensed practical nurses, pharmacy technicians or paramedics hired and are billing under a Pharmacist cannot administer and bill for children under 2 years of age. For more information, please refer to the following links:

The seasonal quadrivalent influenza vaccine for 2021-2022, as per the recommendations by the World Health Organization for northern hemisphere, contains:

• an A/Victoria/2570/2019 pdm09-like virus
• an A/Cambodia/e0826360/2020 -like virus
• a B/Washington/02/2019 -like virus and
• a B/Phuket/3073/2013 -like virus.

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.

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Incidence Of Solicited Local Adversereactions And Systemic Adverse Reactionswithin 7 Daysa Of Vaccination In Adultsb1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=number of subjects with diary card completed.

• aSeven days included day of vaccination and the subsequent 6 days.
• bTrial 1: NCT01204671.
• cContained the same composition as FLUARIX manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
• dContained the same composition as FLUARIX manufactured for the 2010-2011 season .
• eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
• fGrade 3 pain: Defined as significant pain at rest prevented normal everyday activities. Grade 3 redness, swelling: Defined as > 100 mm. Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity. Grade 3 fever: Defined as > 102.2 °F .
• gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
• hFever: Defined as 99.5 °F .

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Call 1-855-475-4QIV

FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccines. FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are approved for use in persons aged 6 months and older.

Please see full Prescribing Information for FLUARIX QUADRIVALENT.

What Are Some Of The Risks Associated With Fluarix Quadrivalent

According to GSK, the most significant risks associated with Fluarix Quadrivalent are: the risk of anaphylaxis for anyone with an allergy to egg protein or who has had an allergic reaction to a flu vaccine in the past the risk of Guillain-Barre Syndrome for individuals who have been diagnosed with GBS following previous flu vaccinations the risk of fainting during vaccine injection and, the risk of experiencing localized pain at the injection site.

However, another risk that is associated with all flu vaccinations is the risk of a shoulder injury related to vaccine administration . These potentially-serious injuries, including adhesive capsulitis and brachial neuritis, result from clinical errors during the vaccine injection and are not specific to any particular type of flu vaccine.

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Fda Approves Sanofi Flu Vaccines For 2022

The FD has approved Sanofis licensure request for vaccine approval for the upcoming 2022-2023 flu season, which would include Fluzone High-Dose Quadrivalent , Flublok Quadrivalent and Fluzone Quadrivalent .

This approval comes on the heels of the CDCs Advisory Committee on Immunization Practices preferential recommendation for adults 65 years old and older, including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent. Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including vulnerable populations of 65 years old and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP.

Influenza disproportionately impacts people over the age of 65 years old and older, underrepresented communities and people with co-morbidities, such as diabetes, asthma, chronic obstructive pulmonary disease and heart disease. Since 2010, its estimated by the CDC that between 70% and 85% of seasonal flu-related deaths have occurred in people 65 years old and older, and between 50% and 70% of seasonal flu-related hospitalizations have occurred among people in this age group. ACIPs June 22 recommendation will undoubtedly help reduce the risk of influenza cases and severe flu-related complications in this population at highest risk, Sanofi said.