Friday, September 22, 2023

High Dose Quadrivalent Flu Vaccine

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Are There Any Side Effects

Oct 20, 2021 ACIP Meeting – Influenza Vaccines

Serious side effects can include severe allergic reactions including swelling of the face, lips, tongue, throat or any other part of the body and which may cause difficulty in swallowing or breathing . See your doctor immediately if you notice this.

Common local side effects include pain, redness, swelling, hardness and bruising at the injection site. Common systemic side effects include muscle aches, feeling unwell, headache, shivering, nausea and tiredness.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Can I Have The Influenza And Covid Vaccine At The Same Time

COVID-19 vaccines can be co-administered with an influenza vaccine. Studies demonstrate the safety and immunogenicity of co-administration of COVID-19 and influenza vaccines.

On this page:Registered products | Vaccines for use in children | Vaccines for use in under 65s | Vaccines for use in over 65s | What is in the influenza vaccine? | Further information | Reporting of adverse events following influenza vaccine

Can You Get Two For Better Coverage

The currently available enhanced vaccines protect against three flu strains, whereas the standard vaccine protects against four.

But for most people, there is no evidence that receiving multiple doses of different vaccines in any one year is any better than getting a single dose of vaccine.

In theory, the four-strain vaccines protect against one more strain than the enhanced three-strain vaccines. But in most seasons, few infections are caused by the fourth strain.

There are some specific groups of people for whom two doses may be recommended, including young children receiving the vaccine for the first time, and some people with bone marrow or organ transplants. Seek advice from your doctor if this describes you or your childrens situation.

Its important to note that none of the standard or enhanced flu vaccines are completely protective they reduce, but dont completely eliminate, the risk of getting influenza.

A single dose of any influenza vaccine in each season is the most effective strategy to reduce your chance of getting influenza.

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Frequently Asked Questions On High Dose Seasonal Influenza Vaccine

What is Fluzone High-Dose Quadrivalent influenza vaccine?Fluzone High-Dose Quadrivalent is an influenza vaccine manufactured by Sanofi Pasteur Inc., designed specifically for people 65 years and older.

What is the difference between regular Influenza vaccine and Fluzone High-Dose?High-Dose vaccine contains four times the amount of antigen contained in regular flu shots. The additional antigen is intended to create a stronger immune response in the person getting the vaccine. This flu season the high dose flu vaccine newly helps protect against four different strains of influenza and is Quadrivalent instead of three in years past.

Why is a higher dose vaccine available for adults 65 and older?Human immune defenses become weaker with age, which places older people at greater risk of severe illness from influenza. Also, ageing decreases the bodys ability to have a good immune response after getting influenza vaccine. A higher dose of antigen in the vaccine is supposed to give older people a better immune response, and therefore, better protection against the flu.

Who can get this vaccine?Fluzone High-Dose Quadrivalent is approved for use in people 65 years of age and older and Atrius Health locations administer the high-dose flu vaccine to patients 65 years and older.

What If The High

Sanofi Pasteur Ships First of its 2016

Manufacturers have increased flu shot production to meet the high demand for the 2020-2021 season. According to the CDC, between 188 million and 200 million doses will be distributed. All vaccines will be quadrivalent , most will be thimerosal-free or thimerosal-reduced vaccines and about 18% of flu vaccines will be free of eggs.

But if you or your loved ones can’t get the high-dose vaccine from your health care provider, pharmacy, or another vaccine site, you can absolutely get the standard-dose vaccine as an alternative, says Dr. Seidman.

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Looking After Your Vaccine

Fluzone High-Dose Quadrivalent is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However, if you need to store Fluzone High-Dose Quadrivalent:

  • Keep Fluzone High-Dose Quadrivalent in the original packaging until it is time for it to be given.
  • Keep it in the refrigerator, store at 2C to 8C. Do not freeze Fluzone High-Dose Quadrivalent.

Do not use Fluzone High-Dose Quadrivalent after the expiry date which is stated on the carton after EXP.

Do not use Fluzone High-Dose Quadrivalent if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

The Centers For Disease Controls 2021

Annual flu vaccination is recommended for everyone six months and older. Different flu shots are approved for people of different ages. In general, if you are pregnant or have an underlying health condition, you should still get a flu shot, but you can talk to your healthcare provider first if you are concerned.

The regular quadrivalent flu vaccine and high dose flu vaccine can be made using several different methods. Below we explain the three ways that flu vaccines are made:

  • Egg Based: Most flu shots are made with egg-based technology. The virus is grown in eggs and incubated for several days before the fluid containing the virus is extracted. The viruses are then killed and purified before being distributed. Even though these vaccines contain a small amount of egg protein, they are safe for people with severe egg allergies.There are egg-based vaccines that also include adjuvants, which are additional ingredients that help promote a better immune response.
  • Cell culture-based: This type of inactivated flu vaccine is made from viruses grown in animal cells instead of eggs. There is currently only one inactivated cell-based flu vaccine that is approved by the FDA. There is some evidence that this type of vaccine may provide stronger protection against the flu than standard egg-based vaccines.
  • Below is a table of the available flu vaccines, the way they are made, and the age range appropriate for each type of vaccination.

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    Are There Benefits Of Fluzone High

    Data from clinical trials comparing Fluzone to Fluzone High-Dose among people 65 years and older indicated that a stronger immune response occured after vaccination with Fluzone High-Dose. A study published in the New England Journal of Medicine indicated that the high-dose vaccine was 24% more effective in preventing flu in adults 65 years and older relative to a standard-dose vaccine. Another study published in The Lancet Respiratory Medicine reported that people 65 years and older who got Fluzone High-dose had a lower risk of hospital admission compared with people in that age group who got the standard-dose Fluzone, especially those living in long-term care facilities. This study was conducted during the 2013-14 flu season among more than 38,000 resident of 823 nursing homes in 38 states.

    For the 2021-22 season, all Fluzone High-Dose vaccine will be quadrivalent. Data comparing the effectiveness of Fluzone High-Dose Quadrivalent with standard-dose inactivated quadrivalent vaccines are not yet available.

    What Is Fluzone High

    NVAC l September 2021 l CDC Flu Vaccine Recommendations, Member Updates, and Public Comment

    Influenza virus is a contagious disease caused by a virus that can spread from one person to another through the air or on surfaces. Flu symptoms include fever, chills, tiredness, aches, sore throat, cough, vomiting, and diarrhea. The flu can also cause sinus infections, ear infections, bronchitis, or serious complications such as pneumonia.

    Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Influenza is most dangerous in children, pregnant women, older adults, and people with weak immune systems or health problems such as diabetes, heart disease, or cancer.

    Fluzone High-Dose Quadrivalent PF 2021-2022 is for use in adults and children at least 6 months old, to prevent infection caused by influenza virus. This vaccine helps your body develop immunity to the disease, but will not treat an active infection you already have.

    Fluzone High-Dose Quadrivalent PF 2021-2022 is redeveloped each year to contain specific strains of inactivated flu virus that are recommended by public health officials for that year.

    The injectable Fluzone High-Dose Quadrivalent PF 2021-2022 is made from “killed viruses.” This medicine is also available in a nasal spray form, which is a “live virus” vaccine. This medication guide addresses only the injectable form of this vaccine.

    Like any vaccine, Fluzone High-Dose Quadrivalent PF 2021-2022 may not provide protection from disease in every person.

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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.

    Ii Canadian Immunization Guide Chapter On Influenza: Clinical Information For Vaccine Providers

    The Canadian Immunization Guide is written primarily for health care providers but it is also used by policy makers, program planners, and the general public. The CIG has been a trusted, reader-friendly summary of the vaccine statements provided by NACI since 1979.

    The information in this section replaces the influenza chapter of the CIG and is adapted for inclusion in the NACI Statement on Seasonal Influenza Vaccine. With a new NACI Statement on Seasonal Influenza Vaccine required each year, readers will have quick access to the information that they require within one document, whether it is the relevant influenza vaccine information written primarily for frontline vaccine providers as is found in this section, or the more detailed technical information that is found in the rest of this statement, commencing in Section III.

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    Iv2 Live Attenuated Influenza Vaccine

    LAIV contains standardized quantities of FFU of live attenuated influenza virus reassortants. The virus strains in LAIV are cold-adapted and temperature sensitive, so they replicate in the nasal mucosa rather than the lower respiratory tract, and they are attenuated, so they do not produce ILI. There have been no reported or documented cases, and no theoretical or scientific basis to suggest transmission of vaccine virus would occur to the individual administering LAIV. As a live replicating whole virus formulation administered intranasally, it elicits mucosal immunity, which may more closely mimic natural infection.

    Vaccine currently authorized for use:

    • FluMist® Quadrivalent
    Efficacy and effectiveness

    After careful review of the available Canadian and international LAIV VE data over many influenza seasons, NACI concluded that the current evidence is consistent with LAIV providing comparable protection against influenza to that afforded by IIV and does not support a recommendation for the preferential use of LAIV in children 2-17 years of age.

    Refer to the Statement on Seasonal Influenza Vaccine for 2018-2019 for detailed information supporting this recommendation.


    LAIV4 has shown non-inferiority based on immunogenicity compared to LAIV3 in both children and adults. The immune response to the B strain found only in the quadrivalent formulation was better in children who received the quadrivalent vaccine Footnote 158, Footnote 159, Footnote 160.


    Vaccines For Use In Under 65s


    Three vaccine brands are being supplied under the NIP in 2022 for people aged under 65 years who are in the following at risk groups: Aboriginal and Torres Strait Islander people, pregnant women, and people who have certain medical conditions: Vaxigrip Tetra, Fluarix Tetra and Afluria Quad. Vaxigrip Tetra and Afluria Quad are registered for all people under the age of 65 years.

    Influvac Tetra and Fluquadri are also registered for use in people under the age of 65 years, however both will be available for purchase on the private market only.

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    Remember No Vaccine Is A Guarantee

    No vaccine is 100% effective in preventing the flu. “The effectiveness of the flu vaccine last year is estimated at around 45 percent,” says Dr. Seidman. “But even though a person can still get the flu after being vaccinated, there is evidence that the severity of the infection can be significantly less in patients who were vaccinated compared to those who were not.”

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    Vaccines For Use In Over 65s

    All eight vaccines in the above table of products are registered for use in those aged over 65 years.

    The adjuvanted QIV, Fluad Quad and the non-adjuvanted Fluzone High-Dose Quadrivalent are specifically for use in elderly.

    Fluad Quad can be used in individuals from 65 years of age and above.

    Fluzone High-Dose Quadrivalent can be used in individuals from 60 years of age and above.

    All people aged 65 years and over are eligible for free influenza vaccines under the NIP.

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    Reporting Of Adverse Events Following Influenza Vaccine

    Health professionals and consumers are encouraged to report all adverse events associated with influenza vaccination in patients of any age to the TGA or through the current arrangements in their state or territory.

    All reports contribute to the TGA’s ongoing monitoring of the safety of influenza vaccines.

    The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a vaccine or medicine.

    • Category:Medicines safety

    This Seasons Flu Vaccines

    Flu Vaccine Update 2022 | American College of Physicians

    This year, 81% of the flu vaccine supply will be quadrivalent meaning it will include the four influenza strains that are anticipated to be the major pathogens in this winters flu season.

    Typically, thats determined by noting the most active strains from last years flu season, and the top strains in the southern hemispheres flu season. Flu viruses go there while we enjoy summer here in the northern hemisphere.

    If you play Scrabble, it might interest you to know that this years vaccine contains an A/Brisbane/02/2018 Apdm09-like virus, an A/Kansas/14/2017 A-like virus, a B/Colorado/06/2017-like virus and a B/Phuket/3073/2013-like virus.

    According to the CDC, those are the strains currently making the early rounds of influenza across the U.S., so that correlation with the vaccine is good news.

    This years Fluzone High-Dose contains just three flu strains , and does not contain the B/Phuket strain, which makes up just 1.6% of flu cases so far this year. But earlier this month, Sanofi Pasteur the French pharmaceutical company that produces Fluzone High-Dose received FDA approval to market a quadrivalent version for the 2020-21 flu season.

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    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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    I1 New Or Updated Information For 2020

    NACI recently reassessed the wording for the recommendation on the vaccination of health care workers and other care providers as a group for whom influenza vaccination is particularly recommended. The existing evidence on HCW influenza vaccination and the reduction of morbidity associated with influenza in patients being cared for by a HCW in health care settings was considered in the context of ethics and acceptability. NACI continues to recommend that, in the absence of contraindications, HCWs and other care providers in facilities and community settings should be vaccinated annually against influenza, and recommends the inclusion of this group among the particularly recommended recipients of influenza vaccine. NACI considers the receipt of influenza vaccination to be an essential component of the standard of care for all HCWs and other care providers for their own protection and that of their patients. This group should consider annual influenza vaccination as part of their responsibilities to provide the highest standard of care.

    Recommendation on the use of LAIV in HIV-infected individuals

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    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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