Saturday, September 16, 2023

High Dose Flu Vaccine Manufacturer

Must read

Vaccines For Use In Over 65s

Manufacturing delay causes shortage of high-dose flu shot for seniors

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.

What Vaccine Is Publicly Available For This Influenza Season

The following influenza vaccines are available for the Universal Influenza Program for the 2021-2022 influenza season:

  • QIV injectable inactivated quadrivalent vaccine for both adults and children 6 months of age and older.
  • HD QIV is recommended for adults aged 65 years and older.
  • QIV Live attenuated vaccine nasal spray for healthy children age 2 to 17 years. Flumist® will be provided to Health PEI Public Health Nursing for public clinics, pediatric units in hospital and physicians/nurse practitioners for children in their practice.
  • Study Of A Quadrivalent High

    The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
    Recruitment Status : Active, not recruitingFirst Posted : July 20, 2021Last Update Posted : December 1, 2021
    • Study Details
    Condition or disease
    Biological: Quadrivalent Inactivated Influenza High DoseBiological: COVID-19 mRNA Vaccine Phase 2
    Layout table for study information

    Study Type :
    Official Title: A Phase II, Open-label Study to Assess the Safety and Immunogenicity of Fluzone® High-Dose Quadrivalent , 2021-2022 Formulation and a Third Dose of Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Adults 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
    Actual Study Start Date :
  • Number of participants with immediate adverse events Unsolicited systemic AEs that occur within 30 minutes after vaccination
  • Number of participants with solicited injection site reactions or systemic reactions Number of participants with solicited injection site reactions and systemic reactions
  • You May Like: Has The Flu Season Started Yet

    Iv6 Additional Vaccine Safety Considerations

    Influenza vaccine is safe and well tolerated. Contraindications, precautions, and common AEs are described in Section II. Additional information regarding egg-allergic individuals and GBS is provided below.

    Egg-allergic individuals

    After careful review of clinical and post-licensure safety data, NACI has concluded that egg-allergic individuals may be vaccinated against influenza using any influenza vaccine, including egg-based vaccines and LAIV, without prior influenza vaccine skin test and with the full dose, irrespective of a past severe reaction to egg and without any particular consideration, including vaccination setting. The amount of trace ovalbumin allowed in influenza vaccines that are authorized for use in Canada is associated with a low risk of AE, and in addition, two of the authorized products do not contain any ovalbumin. The observation period post-vaccination is as recommended in Vaccine Safety in Part 2 of the CIG. As with all vaccine administration, vaccine providers should be prepared with the necessary equipment, knowledge, and skills to respond to a vaccine emergency at all times.

    Refer to the Statement on Seasonal Influenza Vaccine for 20182019 for safety data supporting this recommendation for IIV and LAIV.

    Guillain-Barré syndrome

    Noninferiority Of Flulaval Quadrivalent Relative To A Comparator Quadrivalent Influenzavaccine At 28 Days Post

    Special flu vaccine designed to boost immune response in seniors ...

    Adjusted GMTs Against Strains

    CI=confidence interval

    • aTrial 4: NCT02242643.
    • bAccording-to-protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.
    • cNoninferiority to the comparator vaccine defined as adjusted GMTs with the upper limit of the 2-sided 95% CI for the GMT ratio 1.5 and the seroconversion rates upper limit of the 2-sided 95% CI for the difference between the comparator vaccine and FLULAVAL QUADRIVALENT 10%.
    • dA 0.5-mL dose containing 15 mcg each of A/California/07/2009 , A/Texas/50/2012 , B/Massachusetts/02/2012 , and B/Brisbane/60/2008 .
    • eA 0.25-mL dose of US-licensed quadrivalent, inactivated influenza vaccine containing 7.5 mcg each of A/California/07/2009 , A/Texas/50/2012 , B/Massachusetts/02/2012 , and B/Brisbane/60/2008 .
    • fSeroconversion defined as a 4-fold increase in post-vaccination antibody titer from pre-vaccination titer 1:10, or an increase in titer from < 1:10 to 1:40.

    Recommended Reading: How Much Does Cvs Charge For Flu Shot

    Table 1 Influenza Vaccines United States 202021 Influenza Season*

    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
    Flucelvax Quadrivalent
    High dose, egg based
    Fluzone High-Dose Quadrivalent
    Standard dose, egg based with MF59 adjuvant
    Fluad Quadrivalent
    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.

    Iii2 Efficacy And Effectiveness

    Four studies comparing the relative efficacy of high dose vaccines were identified and described below.

    The relative efficacy of Fluzone®High Dose compared with Fluzone® has been evaluated in two studies to date. The first study of 9158 ambulatory, medically-stable adults 65 years and older was conducted in 2009-2010 during the H1N1 pandemicFootnote 21. The relative efficacy was 12.5% in favour of Fluzone®High Dose against laboratory-confirmed influenza, but with exceedingly wide confidence bounds in this study 21 of the 22 symptomatic cases of influenza were caused by the Apdm09 strain, which was not in the seasonal vaccine.

    The second study was conducted in 2011-2012 and 2012-2013 Footnote 22. In this study of almost 32,000 older adults, 18-24% fewer illnesses caused by influenza occurred in people who received Fluzone®High Dose compared with those who received Fluzone®. The relative efficacy against laboratory-confirmed influenza of the high dose vaccine compared to the standard dose vaccine was 18% in participants who provided swabs when they had an acute respiratory illness, with 2.0% and 2.4%, respectively, diagnosed with influenza. The relative efficacy against laboratory-confirmed influenza was 24% , with 1.4% and 1.9%, respectively, diagnosed with influenza, in those who provided swabs when they had an influenza-like illness ).

    You May Like: Salt Lake County Health Department Flu Shots

    Side Effects And Risks

    Fluzone and Fluad can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

    Mild side effects

    These lists contain up to 10 of the most common mild side effects that can occur with each vaccine, or with both Fluzone and Fluad when theyre used individually.

    • Can occur with Fluzone:

    get a flu vaccine thats appropriate for their age during flu season. The CDC doesnt state a preference for one influenza vaccine product over another.

    /2022 Universal Influenza Immunization Program

    Is there a shortage of high dose flu vaccines in DC, Virginia and Maryland?

    The following provides information about the Ontario Ministry of Health Universal Influenza Immunization Program for the 2021/2022 influenza season. The UIIP offers influenza vaccine free of charge each year to all individuals six months of age and older who live, work or go to school in Ontario.

    Vaccination against influenza will be important this fall given the potential for the co-circulation of COVID-19. Preventing the flu will be important not only to protect individual health and the health of families and communities, but also to protect and mitigate impacts on our health care system.

    Don’t Miss: Does Cvs Accept United Healthcare For Flu Shots

    Mild Side Effects Of Fluzone High

    Below we describe mild side effects* of both Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent. Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or dont go away, talk with your doctor or pharmacist.

    Mild side effects of both Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent in adults can include:

    • feeling tired or unwell
    • muscle aches
    • pain, redness, or swelling at the injection site

    * The list above is a partial list of mild side effects from Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent. To learn about other mild side effects, talk with your doctor or pharmacist, or visit the prescribing information for Fluzone High-Dose Quadrivalent influenza vaccine and Fluzone Quadrivalent influenza vaccine.

    Flucelvax Quadrivalent Vaccine News For 2021

    – The CDC that there have been 5 pediatric deaths this flu season.

    – Reporting on data up to December 5, 2021, the WHO encouraged that with the increasing detections of influenza during the COVID-19 pandemic, countries are encouraged to enhance integrated surveillance to monitor influenza and SARS-CoV-2 at the same time, and step-up their influenza vaccination campaign to prevent severe disease and hospitalizations in high-risk groups of influenza.

    – The Lancet published results of a UK phase 4 study in which adults received concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of CO ID-19 vaccine. 3 weeks later the group who received a placebo received the influenza vaccine nd vice versa. Concomitant vaccination with ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine raised no safety concerns and preserved antibody responses to both vaccines.

    – The WHO reported globally influenza activity continues to remain at lower levels than expected.

    – For week 41, the CDC reported nationwide, 1.8% of patient visits reported through ILINet w re due to ILI. This percentage is below the national baseline of 2.5%.

    – New Jersey-based Seqirus announced that the U.S. FDA had Approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.

    – 8 influenza-positive cases were reported in week 40 by the UK respiratory Datamart.

    Recommended Reading: Does The Flu Shot Make Your Arm Sore

    Ii5 Choice Of Seasonal Influenza Vaccine

    The decision to include specific influenza vaccines as part of publicly funded provincial and territorial programs depends on several factors, including cost-effectiveness evaluation and other programmatic and operational factors, such as implementation strategies. Not all products will be made available in all jurisdictions and availability of some products may be limited therefore, officials in individual provinces and territories should be consulted regarding the products available in individual jurisdictions.

    With the availability of influenza vaccines that are designed to enhance immunogenicity in specific age groups, the choice of product has become more complex.

    Choice of influenza vaccine by age group

    Recommendations for individual-level decision making
    • NACI recommends that influenza vaccine should be offered annually to anyone 6 months of age and older who does not have a contraindication to the vaccine. Table 2 provides age group-specific recommendations for the age-appropriate influenza vaccine types authorized for use in Canada.
    Recommendations for public health program-level decision making
    • NACI recommends that any of the age-appropriate influenza vaccine types available for use may be considered for people without contraindications to the vaccine. Table 2 provides age group-specific recommendations for the age-appropriate influenza vaccine types authorized in Canada.

    What If The High

    Wash U. professor has a business solution for flu vaccine shortages ...

    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.

    Also Check: What Medicine Treats The Flu

    If Ive Had A Flu Vaccine In The Past Do I Need To Have Another One

    Yes. Even if youve received an influenza vaccine in the past, youll likely need to get another one each year.

    In fact, the Centers for Disease Control and Prevention recommends that most people older than 6 months of age receive a flu vaccine, such as Fluzone, every year. This is for two main reasons.

    First, many different strains of influenza circulate each year. And these strains are continuously changing. Each year, scientists try to determine which strains of the flu will be the most common in the upcoming flu season. Then these strains are put into flu vaccines, such as Fluzone. So flu vaccines change from year to year.

    Second, the protection provided by the vaccine wanes over time. This effect happens in everyone, but its more likely to occur in older adults .

    If you have questions about getting an annual flu shot, talk with your doctor or pharmacist.

    Serious Side Effects Of Fluzone High

    Serious side effects from both Fluzone High-Dose Quadrivalent and Fluzone Quadrivalent arent common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think youre having a medical emergency.

    Serious side effects of both vaccines, and their symptoms, can include:

    • Allergic reaction, which is described in more detail in the Side effects detail section below.

    Recommended Reading: Mucinex Fast Acting Cold And Flu

    Iii1 People At High Risk Of Influenza

    All children 659 months of age

    On the basis of existing data, NACI recommends the inclusion of all children 659 months of age among those for whom influenza vaccine is particularly recommended.

    Refer to the Statement on Seasonal Influenza Vaccine for 20112012 for additional details on children 623 months of age and to the Statement on Seasonal Influenza Vaccine for 20122013 for children 2459 months of age.

    Adults and children with chronic health conditions

    A number of chronic health conditions, as noted in List 1, are associated with increased risk of influenza-related complications, and influenza can lead to exacerbation of the chronic disease. Influenza vaccination can induce protective antibody levels in a substantial proportion of adults and children with immune compromising conditions, including transplant recipients, those with proliferative diseases of the hematopoietic and lymphatic systems, and HIV-infected people. Vaccine effectiveness may be lower in people with immune compromising conditions than in healthy adults.

    Neurologic or neurodevelopment conditions

    All pregnant individuals

    Very limited peer-reviewed, published data pertaining to safety of vaccination with RIV4 during pregnancy is currently available to inform vaccine-associated risks. Refer to the Supplemental Statement on Recombinant Influenza Vaccines, which will be forthcoming, for more information.

    People of any age who are residents of nursing homes and other chronic care facilities

    Live Vaccines Vs Inactivated Vaccines In Pregnancy

    VERIFY: The truth on whether there is a flu vaccine shortage

    If youre pregnant, its important that you get an inactivated flu vaccine, such as Fluzone. You shouldnt get any live vaccines while youre pregnant.

    Inactivated flu vaccines contain a dead version of the flu virus. These vaccines dont contain a live version of the flu virus. Live flu vaccines, on the other hand, do contain live forms of the flu virus. An example of a live flu vaccine is FluMist, which is given as a spray into your nose rather than as an injection.

    The CDC recommends avoiding live vaccines during pregnancy as they may be harmful to a developing fetus. This is because, in theory, a live vaccine may transfer a virus to the fetus, causing an infection.

    , Fluzone influenza vaccine is safe to take during pregnancy. So you dont need to avoid pregnancy simply because youre receiving Fluzone.

    For more information about taking Fluzone during pregnancy, see the Fluzone and pregnancy section above.

    It isnt known whether Fluzone influenza vaccine passes into human breast milk.

    According to the Centers for Disease Control and Prevention , vaccines given to a breastfeeding female dont affect the safety of breastfeeding children. In fact, the CDC states that flu vaccination can increase the amount of influenza antibodies in breast milk. And this may offer added flu protection to a child whos breastfed.

    But keep in mind that children who are breastfed should still receive their own flu vaccine once theyre at least 6 months of age.

    Also Check: Penn State Health Flu Shots

    What Age Do I Need To Be To Take Fluzone

    This depends on the form of Fluzone youre taking:

    • Fluzone Quadrivalent is approved for use in people ages 6 months and older.
    • Fluzone High-Dose Quadrivalent is approved for use in adults ages 65 years old and older.

    For more information on which form of Fluzone you should take based on your age, see the Fluzone dosage section above. And if you have additional questions about which flu vaccine is best for you, talk with your doctor or pharmacist.

    More articles

    Popular Articles