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Flu Shot Multi Dose Vial

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Immunogenicity Of Fluzone Quadrivalent In Adults 18 Years Of Age

Multidose Vial (MDV)

In Study 3 , 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set .

HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria .

Table 12: Study 3: Non-inferiority of Fluzone Quadrivalent Relative to TIV for Each Strain by HI Antibody GMTs at 21 Days Post-Vaccination, Adults 18 Years of Age and Older


What Is Thimerosal Is It The Same As Mercury

  • Thimerosal is a mercury-containing organic compound and has been used for decades in the United States and other countries. Its used as a preservative in a number of biological and drug products, including many vaccines, to help prevent potentially life threatening contamination with harmful microbes.
  • Mercury is a metal found naturally in the environment and affects the human body differently than thimerosal.

What Is The Correct Dosage Of Vaccine

The amount of inactivated vaccine that should be administered intramuscularly is based on the patients age and the vaccine product you are using.

  • For children 635 months of age, the correct dosage is:
  • 0.25 mL for Afluria Quadrivalent
  • 0.5 mL for Fluarix Quadrivalent
  • 0.25 mL or 0.5 mL for Fluzone Quadrivalent
  • 0.5 mL for FluLaval Quadrivalent
  • For persons 3 years of age and older, the correct dosage is 0.5 mL for most inactivated influenza vaccine products. Fluzone High-Dose Quadrivalent is for use in persons 65 years of age and older, and the correct dosage is 0.7 mL.
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    Filling The Syringe With Medicine

    Follow these steps to fill the syringe with medicine:

    • Hold the syringe in your hand like a pencil, with the needle pointed up.
    • With the cap still on, pull back the plunger to the line on your syringe for your dose. This fills the syringe with air.
    • Insert the needle into the rubber top. Do not touch or bend the needle.
    • Push the air into the vial. This keeps a vacuum from forming. If you put in too little air, you will find it hard to draw out the medicine. If you put in too much air, the medicine may be forced out of the syringe.
    • Turn the vial upside down and hold it up in the air. Keep the needle tip in the medicine.
    • Pull back the plunger to the line on your syringe for your dose. For example, if you need 1 cc of medicine, pull the plunger to the line marked 1 cc on the syringe. Note that some bottles of medicine may say mL. One cc of medicine is the same amount as one mL of medicine.

    To remove air bubbles from the syringe:

    • Keep the syringe tip in the medicine.
    • Tap the syringe with your finger to move air bubbles to the top. Then push gently on the plunger to push the air bubbles back into the vial.
    • If you have a lot of bubbles, push the plunger to push all the medicine back into the vial. Draw medicine out again slowly and tap air bubbles out. Double check that you still have the right amount of medicine drawn up.
    • Remove the syringe from the vial and keep the needle clean.
    • If you plan to put the syringe down, put the cover back on the needle.

    What Keeps Todays Childhood Vaccines From Becoming Contaminated If They Do Not Contain Thimerosal As A Preservative

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    • The childhood vaccines that used to contain thimerosal as a preservative are now put into single-dose vials or syringes, so no preservative is needed. In the past, these vaccines were put into multi-dose vials, which could become contaminated when new needles were used to get vaccine out of the vial for each dose.

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    Can Live Attenuated Influenza Vaccine Be Given At The Same Time As Other Vaccines

    Live, attenuated influenza vaccine may be administered simultaneously with other live or inactivated vaccines. However, if two live, attenuated vaccines are not given during the same clinical visit, they should be separated by at least 4 weeks to minimize the potential risk for interference. For example, if live, attenuated influenza vaccine was given, at least 4 weeks should pass before MMR is administered.

    Can Inactivated Influenza Vaccine Be Given At The Same Time As Other Vaccines Such As Pneumococcal Polysaccharide Or Zoster Vaccines

    Yes if other vaccines are indicated, they can be administered during the same clinical encounter as inactivated influenza vaccine. When giving several injections at a single visit, administer each vaccine at a separate injection site. The injection sites should be separated by 1 inch or more, if possible, so that any local reactions can be differentiated.

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    Should I Repeat A Dose Of Injectable Influenza Vaccine Administered By An Incorrect Route

    Yes if a formulation labeled for intramuscular injection is given by the subcutaneous or intradermal route, it should be repeated. The dose may be administered as soon as possible. There is no minimum interval required between the invalid dose and the repeat dose.

    Administering vaccine by the wrong route is considered a vaccine administration error. Healthcare personnel should take steps to determine how the error occurred and put strategies in place to prevent it from happening in the future.

    In addition, we encourage providers to report all vaccine administration errorseven those not associated with an adverse eventto the Vaccine Adverse Event Reporting System external icon. A discussion of strategies to prevent errors can be found in theVaccine Administration chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases . Additional resources can be found on CDCs vaccine administration web page.

    Do Flu Vaccines Contain Thimerosal

    Episode 8a: How Do I Safely Use a Multi-Dose Vaccine Vial? Part 1

    Flu vaccines in multi-dose vials contain thimerosal to safeguard against contamination of the vial. Most single-dose vials and pre-filled syringes of flu shot and the nasal spray flu vaccine do not contain a preservative because they are intended to be used once.

    A list of available flu vaccines and their thimerosal content is available.

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    A Staff Member Inadvertently Administered The Wrong Dosage Of Influenza Vaccine How Do We Correct This

    If a smaller than recommended dose of any inactivated influenza product is inadvertently administered, additional vaccine should be given so that the patient receives a full dose. The amount of vaccine that should be administered is based on when the patient is available to be revaccinated. For example:

    • If a partial dose of an inactivated influenza vaccine product is administered and revaccination can occur on the same clinic day, the patient should receive a remaining volume to total the correct dosage. For example, if the correct dosage for the patient is 0.5 mL and they received only 0.25 mL, an additional 0.25 mL should be given if revaccination can occur on the same day.
    • If the patient cannot be revaccinated until the next day or later, a full dose of inactivated influenza vaccine should be administered as soon as the patient can return.
    • If a larger dose of influenza vaccine is inadvertently administered, count the dose as valid. Revaccination with additional vaccine is not needed.

    Giving an incorrect dose is considered a vaccine administration error. Healthcare personnel should take steps to determine how the error occurred and put strategies in place to prevent it from happening in the future.

    Why Are Preservatives Sometimes Used In Vaccines

    Preservatives are used to protect vaccines packaged in multi-dose vials. Each time a vaccine dose is drawn from a multi-dose vial, bacteria or fungi can enter the vial. Receiving a vaccine contaminated with bacteria or fungi can be dangerous. Preservatives are needed to prevent contamination of multi-dose vials each time individual doses are drawn.

    Thimerosal use in vaccines and other medical products has a record of being very safe. Data from many studies show no evidence of harm caused by the low doses of thimerosal in vaccines.

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    Was Thimerosal Used In All Childhood Vaccines

    • No. Some other vaccines, including the measles, mumps, and rubella vaccine , do not and did not ever contain thimerosal or any preservative. Varicella , inactivated polio , and pneumococcal conjugate vaccines have also never contained thimerosal.
    • There is no thimerosal used in the vaccines on the childhood immunization schedule.

    Do I Need A Preservative

    Trump administration likely to

    Unless flu vaccination is contraindicated for you, there is no safety-related reason to avoid getting a traditional flu shot.

    With that said, if you would prefer to avoid thimerosal, ask your healthcare provider if they have a preservative-free flu vaccine available. Alternatively, you can ask your healthcare provider if FluMist nasal spray vaccine is an option for you.

    While the FluMist vaccine is preservative-free, it contains a live weakened virus and should not be used in people with a compromised immune system, children under two years, adults 50 and over, pregnant women, and people with a severe, life-threatening reaction to flu shots or any of their ingredients.

    Be aware that most clinics and pharmacies will only have one or two types of vaccine on hand . A special order would need to be placed for you if you would like something different.

    Because it takes two weeks for the body to produce enough defensive antibodies, the vaccination should be done early in the season to avoid infection.

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    Single Vial Vs Multiple Vial Flu Vaccine

    Each year the Centers for Disease Control and Prevention makes a nationwide push to increase vaccination rates against influenza, a viral respiratory disease that kills approximately 6,000 Americans and sickens many more every winter. Immunization against flu is recommended for everyone over 6 months of age. To meet this annual demand, vaccine manufacturers must begin production several months ahead of each flu season, which typically begins around October in northern latitudes. Influenza vaccines were almost universally packaged in multiple-dose vials until the late 1990s, when public concerns over preservatives forced a change in manufacturing practices.

    Cost Of Disposal Of Vaccine Vials

    As Table 1 shows, the different vial presentations result in different volumes of medical waste incurring additional costs. A second cost scenario added the costs of discarding used vaccine vials. In this segment of the analysis, the cost of disposal of reconstitution syringes was also considered, while the cost of disposal of injection syringes was not included. The cost of the injection syringe does not change as vial size changes since a new injection syringe is used for each arriving patient. The cost of the reconstitution syringe changes as the vial size changes and becomes less costly per dose as the doses per vial increases. Table 1 also shows the medical waste from each vial presentation and the associated costs. The medical waste generated is:

    Total Weight of Discarded Vials = Number of Vials Used × Weight per Vial

    Total Weight of Discarded Reconstitution Syringes = Number of Vials Used × Weight per Syringe

    The cost of discarded medical waste is:

    Total Cost of Medical Waste = × Cost per Kg of Medical Waste Discarded

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    Efficiency & Costs: Baltimore Study


    The efficiency, costs and safety practices related to influenza vaccination were evaluated in a time-motion study. Seven practices in Baltimore and the metropolitan area participated in the study. The practices included hospitals, clinics and private medical centers. The sites varied in their location three were urban and four suburban. Five practices provided both seasonal and H1N1 influenza vaccines, whereas two only provided the seasonal influenza vaccine. We observed 31 immunization professionals , all of whom were registered nurses with various years of experience, ranging from 3 to 39 years . The practices sampled were selected based on their willingness to participate in the study and permission was obtained from each healthcare provider to have their immunization-related activities observed and timed. Observations and data collection took place between October 2009 and March 2010.

    Data Collection

    Cost Measurement

    Healthcare professionals’ salaries were obtained through the US Bureau of Labor Statistics website, statistics for the year 2009. We utilized mean wages for registered nurses in the state of Maryland, USA.

    Disposal/waste cost difference was assumed to be negligible, as we pressumed that hospitals and clinics already have a contracted waste service and the choice of MDVs or PFSs would not lead to additional waste disposal collection visits.

    Statistical Analyses: Time Use Estimation


    Figure 2.


    Cost Of Vaccine Vials

    Episode 8b: How Do I Safely Use a Multi-Dose Vaccine Vial? Part 2

    The first scenario considered only the cost of the vaccine, i.e., cost of doses used and doses wasted. Table 1 shows the cost per dose for each vaccine presentation. The cost of vaccine wastage was determined as follows:

    Cost of Vaccine Wastage = Cost per Dose × Number of Doses Wasted

    Therefore, the total cost of vaccination for each presentation is:

    Total Vaccine Costs = Cost of Vaccines Used + Cost of Vaccine Wastage = +

    The cost per vaccinated patient then is:

    Cost per Vaccinated Patient = Total Vaccine Costs /Number of Vaccinated Patients

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    Why Is Thimerosal Still In Some Flu Vaccines That Children May Receive

    • To produce enough flu vaccine for the entire country, some of it must be put into multi-dose vials. These vials have very tiny amounts of thimerosal as a preservative. This is necessary because each time an individual dose is drawn from a multi-dose vial with a new needle and syringe, there is the potential to contaminate the vial with harmful microbes . So, this preservative is needed to prevent contamination of the vial when individual doses are drawn from it, and keep the children safety who are receiving the flu shot from the multi-dose vial. Children can safely receive flu vaccine that contains thimerosal.
    • Flu vaccine that does not contain thimerosal is available in single-dose vials or single-dose syringes. One formulation of single-dose inactivated flu vaccine, Fluvirin, contains trace amounts of thimerosal.

    Learn About The Safety Of Thimerosal A Preservative Used In Some Vaccines

    A preservative-free flu shot is a type of flu vaccine that does not contain the antimicrobial agent known as thimerosal. Thimerosal, a mercury-based compound, is an ingredient in some vaccines because it prevents the growth of bacteria, fungus, or other microorganisms that might contaminate a vial when a needle is inserted.

    Some people seek out preservative-free vaccinations because they’ve heard that vaccine ingredients like thimerosal can cause autism, a claim that clinical researchers have repeatedly been debunked.

    According to the Centers for Disease Control and Prevention , the side effects of flu shots containing thimerosal are ultimately the same as those that are preservative-free.

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    The Need For A Preservative

    All vaccines, including those designed to protect you from influenza, contain biological agents whose shelf lives are limited. Since the 1930s, many vaccine products have been manufactured with thimerosal, a mercury-based preservative that extends vaccine shelf life and reduces the risk for bacterial or fungal contamination. Including thimerosal in vaccines permits manufacturers to store their products before the flu season, and it facilitates the use of multi-dose vials, which reduces the costs of production and saves money for consumers — or their insurance companies.

    Recommended Dose And Schedule

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    FLULAVAL should be administered as a single 0.5-mL injection by the intramuscular route preferably in the region of the deltoid muscle of the upper arm.

    The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. A needle length of 1 inch is preferred because needles < 1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

    Do not administer this product intravenously, intradermally or subcutaneously.

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    The Cost Of Vaccine Wastage Plus Vaccine Vial Disposal

    Figure 3b shows the effects of adding the cost of vaccine vial disposal to the costs of the measles vaccine. As can be seen, while this does increase the cost per vaccinated patient, it does not significantly change the most economic choice for different mean daily patient arrival rates. These results confirm that the cost of vaccine wastage far outweighs any added cost from having to dispose of more vaccine vials with different vaccine formats.

    Similarly, as highlighted in Table 2, the relative costs of the different YF, BCG, and Hib vaccine presentations do not change significantly. The mean daily patient arrival thresholds at which 20-dose BCG vaccine and the 10-dose Hib vaccine become favorable remain at 7 and 6 respectively. The threshold for YF changes slightly, with the 5-dose YF vaccine being the least costly option when mean daily patient arrival is 32 or below and the 50-dose for higher arrival rates.

    Acceptability curves further confirm these findings. Figure 4b demonstrates that for mean daily patient arrival rates of 1 and 2 patients, the 1-dose measles vial size is the most cost effective option 100% of the time. For mean daily patient arrival rates from 3 to 50 patients, the 10-dose vial size is the most cost effective option between 99% and 100% of the time. Acceptability curves for the other vaccines also support the findings in Table 2.

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