Friday, September 22, 2023

High Dose Flu Vaccine Recommendations

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New And Emerging Research Priorities

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

Efficacy, effectiveness, immunogenicity and safety

  • What is the population effectiveness and medium and long-term durability of protection of a single dose or a complete series of each COVID-19 vaccine approved in Canada?
  • What is the efficacy, effectiveness, immunogenicity, and safety of COVID-19 vaccines across diverse population groups ? Is a third booster dose of vaccine or a higher dose of vaccine needed to elicit an appropriate immune response in these individuals?
  • What is the efficacy, effectiveness, immunogenicity and safety of COVID-19 vaccines in individuals who have had a previous laboratory evidence of SARS-CoV-2 infection?
  • Is there a discernable difference between seronegative and seropositive people in any of the above parameters?
  • Does previous exposure to SARS-COV-2 impact efficacy, effectiveness, immunogenicity or safety of COVID-19 vaccines?
  • Can a single-dose vaccine series be as effective and safe in individuals with previously proven COVID-19 disease?
  • Are there any emerging safety signals with COVID-19 immunization that are not predicted by the current understanding of the safety profile of similar vaccines?
  • Does vaccination following prior SARS-CoV-2 infection or vaccination of SARS-CoV-2 naïve individuals elicit enhanced or altered disease upon subsequent infection by SARS-CoV-2 or other endemic coronaviruses?
  • What is the efficacy, effectiveness, immunogenicity and safety of COVID-19 vaccines against SARS-CoV-2 variants of concern?
  • Vaccine administration

    Keeping Our Patients Safe From The Flu

    Michigan Medicine has joined dozens of health care institutions throughout the country in requiring staff to be vaccinated against flu or to wear a protective mask during any patient interaction during flu season. The requirement is designed to help protect the health of our patients and their families and will especially protect the many people we care for who have serious medical conditions and weakened immune systems.

    FOR EMPLOYEES: Please visit our employee flu prevention site for more details for more information about our employee flu shot policy and upcoming employee flu shot clinics.

    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.

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    Timing Of Influenza Vaccination

    Annual influenza vaccination is recommended before the influenza season starts. Influenza circulation usually peaks between June and September in most parts of Australia. However, influenza can occur year-round.

    Protection is expected to last for the whole season, but optimal protection is within the first 34 months after vaccination. Deferring vaccination to the beginning of winter may result in greater immunity later in the season, but may also result in missed opportunities for vaccination and lack of protection if the influenza season starts early.

    Immunisation providers need to weigh up these factors for each person, and balance them with the challenge of vaccinating large numbers of people in a short time.

    Offer vaccination throughout the influenza season. It is never too late to vaccinate, because influenza can circulate all year. In particular, pregnant women and travellers can benefit from vaccination at any time of the year.

    Children aged 6 months to < 9 years who are receiving their 1st lifetime dose should receive the vaccine as soon as possible after it becomes available. This helps to ensure enough time to receive a 2nd dose before the influenza season starts.

    The only absolute contraindications to influenza vaccines are:

    • anaphylaxis after a previous dose of any influenza vaccine
    • anaphylaxis after any component of an influenza vaccine

    See Precautions for more details about influenza vaccination for people with a known egg allergy.

    Is Moderna Working On Other Covid Vaccine Boosters

    Prevention and Control of Seasonal Influenza with Vaccines ...

    On Monday, Moderna’s Hoge said with its current 50-microgram COVID booster authorized by the Food and Drug Adminstration, you get “quite respectable” protection. The company contines to study an omicron-specific vaccine and an multivaliant vaccine that could protect against other variants, including the alpha and delta strains in case either is needed. The company said it is also studying a 100-microgram version of its booster that can raise antibody protection 83 fold.

    Hoge said Moderna could have new versions of its vaccine ready early in 2022 but is not planning to ask the CDC and FDA to amend its booster authorization for the 100-microgram trial version of its booster.

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    All People Aged 6 Months

    Registered for use in people aged 6 months.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains
    • 0.05 µg ovalbumin

    Registered for use in people aged 6 months.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains
    • 100 µg formaldehyde

    Registered for use in people aged 6 months.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains

    Also contains traces of:

    Registered for use in people aged 3 years.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains
    • 100 ng ovalbumin

    Registered for use in people aged 5 years.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains
    • < 1 µg ovalbumin

    Registered for use in people aged 9 years.

    Quadrivalent inactivated influenza vaccine

    Each 0.5 mL monodose pre-filled syringe contains:

    • 15 µg haemagglutinin of each of the 4 recommended influenza virus strains

    May contain traces of:

    Registered for use in people aged 65 years.

    Adjuvanted quadrivalent inactivated influenza vaccine

    People Capable Of Transmitting Influenza To Those At High Risk Of Influenza

    • Healthcare workers and other care providers in facilities and community settings
    • Household contacts, both adults and children, of individuals at high risk, whether or not the individual at high risk has been vaccinated, such as:
    • household contacts and care providers of infants less than 6 months of age
    • members of a household expecting a newborn during the influenza season
  • Those providing regular child care to children 0 to 59 months of age, whether in or out of the home
  • Those who provide services within closed or relatively closed settings with people at high risk
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    National Vaccine Injury Compensation Program

    The National Vaccine Injury Compensation Program , established by the National Childhood Vaccine Injury Act of 1986, as amended, provides a mechanism through which compensation can be paid on behalf of a person determined to have been injured or to have died as a result of receiving a vaccine covered by VICP. The Vaccine Injury Table lists the vaccines covered by VICP and the associated injuries and conditions that might receive a legal presumption of causation. If the injury or condition is not in the Table or does not occur within the specified period in the Table, persons must prove that the vaccine caused the injury or condition. Eligibility for compensation is not affected by whether a covered vaccine is used off-label or inconsistently with recommendations.

    Live Attenuated Influenza Vaccine

    Local pharmacists report limited supply of high-dose flu vaccine

    Children 2-17 years of age who are eligible for an influenza vaccine can receive FluMist® Quadrivalent by nasal spray.

    The nasal spray vaccine will be available at health units, some pharmacies and some doctors’ offices. Pharmacists will be able to give the nasal spray flu vaccine to children 2 years of age and older. The Influenza Clinic locator will list if a nasal spray vaccine is available at that clinic. Call ahead to confirm. The nasal spray vaccine is not approved for use in those younger than 2 years of age and they should receive their influenza vaccine by needle.

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    Vaccine Safety And Adverse Events Following Immunization

    Due to limitations in the number of participants and duration of follow-up from COVID-19 clinical trials, medium- and long-term evidence on vaccine safety is limited. However, post-licensure vaccine pharmacovigilance is ongoing and safety signals around the world are detected and communicated globally. Clinical trials of the authorized COVID-19 vaccines excluded individuals with a history of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the vaccine. However, studies are ongoing.

    The following section highlights key safety and AEFI data for the authorized and available COVID-19 vaccines. For additional details regarding trial design, including study population and length of follow-up, and safety for the COVID-19 vaccines authorized for use in Canada, refer to the evidence summaries in Appendix A , Appendix B , Appendix C , and Appendix D . Refer to Appendix E for a summary of the frequency of AEFI for the different COVID-19 vaccine products.

    Refer to Part 2 – Vaccine Safety in the CIG for definitions of AEFIs and additional general information.

    Very common and common adverse events

    Common adverse events are defined as those that occur in 1% to less than 10% of vaccine recipients very common adverse events occur in 10% or more of vaccine recipients. Please see Appendix E for a summary of adverse events identified in clinical trials of authorized, available COVID-19 vaccines.


    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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    Severe Outcomes Due To Covid

    Severe COVID-19 disease

    Severe COVID-19 disease, defined as study participants who met the confirmed COVID-19 case definition and were assigned a severity score of â¥6 on the World Health Organization Clinical Progression Scale , was assessed as a secondary analysis of vaccine efficacy. Analysis included study participants who had been followed for â¥15 days since Dose 2, who were seronegative for SARS-CoV-2 at baseline, and received both doses of the SD/SD regimen. As of December 7, 2020, there were 6,085 study participants in the vaccine group and 6,073 participants in the control group. There was 1 case of severe COVID-19 disease identified in a study participant in the control group who received the control intervention within the 4-12-week dosing interval. This participant also required ICU admission and eventually died. An additional severe case occurred > 21 days after the first dose and â¤14 days after the second dose in a study participant in the control group.

    Table 13 : Estimates of vaccine efficacy against hospitalization, by dosing interval

    Time period of interest

    As of the updated data cut-off date of December 7, 2020, there has been a single death due to COVID-19 identified in a study participant in the control group.

    The Flu Shot Is Your Best Defence

    Prevention and Control of Seasonal Influenza with Vaccines ...

    This years flu season is taking place at the same time as COVID-19. Dont take any unnecessary risks with your health. Get the flu shot as early in the season as possible.

    The flu shot is recommended for everyone 6 months old and older. It is:

    • safe
    • free
    • available from your doctor or nurse practitioner, and at participating pharmacies and local public health units across the province
    • proven to reduce the number of doctor visits, hospitalizations and deaths related to the flu
    • different each year because the virus changes frequently so you need to get it every fall

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    Fever And Febrile Convulsions In Children Aged < 5 Years

    In 2010, higher rates of fever and convulsions were reported in children aged < 5 years after influenza vaccination, especially in children aged < 3 years.

    Only the Seqirus vaccines Fluvax and Fluvax Junior were associated with this side effect. After vaccination with Fluvax or Fluvax Junior, children < 5 years of age had convulsions at a rate of 4.4 per 1000 doses, compared with no such events reported among children who received an alternative vaccine in the same year.85

    The Fluvax and Fluvax Junior vaccines are no longer available in Australia and available Seqirus vaccines have been reformulated.

    Appendix C: Clinical Trial Evidence Summary For Astrazeneca Vaxzevria Covid

    Results from four clinical trials were available at time of authorization for the AstraZeneca COVID-19 vaccine. Results from an ongoing Phase 3 trial in the United States were not available at time of writing. Evidence on efficacy, immunogenicity, and safety is available for adults â¥18 years of age. The Phase 2/3 trial trial and Phase 3 trial assessed efficacy, safety and immunogenicity of the vaccine. The Phase 2/3 trial was based in the United Kingdom, while the Phase 3 trial was based in Brazil. These two studies underwent a series of protocol amendments and logistical challenges during the conduct of the trials that resulted in significant changes to the trials’ methodology. There were changes from a single to a two-dose vaccine regimen, the use of both a low dose/standard dose and standard dose/standard dose vaccine regimen, and the recruitment of progressively older study participants after the initial focus on adults 18-55 years of age. In the SD/SD vaccine regimen, study participants were randomized to receive either the AstraZeneca COVID-19 vaccine, AZD1222 or control injection. The participants randomized to the control group were administered two doses of quadrivalent meningococcal vaccine or MenACWY for Dose 1 and placebo for Dose 2 .

    Evidence from the AstraZeneca COVID-19 vaccine trials has been publishedFootnote 33. Evidence from post-marketing surveillance and studies is found in the main body of this statement.

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    Storage And Handling Of Influenza Vaccines

    In all instances, approved manufacturer packaging information should be consulted for authoritative guidance concerning storage and handling of specific influenza vaccines. In general, influenza vaccines should be protected from light and stored at temperatures that are recommended in the package insert. Recommended storage temperatures are generally 36°F46°F and should be maintained at all times with adequate refrigeration and temperature monitoring. Vaccine that has frozen should be discarded. Specific recommendations for appropriate refrigerators and temperature monitoring equipment can be found in the Vaccine Storage and Handling Toolkit, available at .

    Cdc Adoption Of Acip Recommendations For Mmwr Recommendations And Reports Mmwr Policy Notes And Immunization Schedules

    Health Watch | High dose flu vaccine

    Recommendations for routine use of vaccines in children, adolescents, and adults are developed by the Advisory Committee on Immunization Practices . ACIP is chartered as a Federal Advisory Committee to provide expert external advice and guidance to the Director of CDC on use of vaccines and related agents for the control of vaccine preventable diseases in the civilian population of the United States. Recommendation for routine use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics , the American Academy of Family Physicians , and the American College of Obstetricians and Gynecologists . Recommendations for routine use of vaccinations in adults are harmonized with recommendations of AAFP, ACOG, and the American College of Physicians . ACIP recommendations approved by the CDC Director become agency guidelines on the date published in the Morbidity and Mortality Weekly Report . Additional information is available at .

    • RIV = Recombinant Influenza Vaccine
    • LAIV = Live Attenuated Influenza Vaccine
  • Numerals following letter abbreviations indicate the number of influenza virus hemagglutinin antigens represented in the vaccine:
  • 4 for quadrivalent vaccines: one A, one A, and two B viruses
  • 3 for trivalent vaccines: one A, one A, and one B virus
  • Prefixes are used when necessary to refer to some specific inactivated vaccine types:
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    Is The Moderna Booster Shot A Third Dose

    Booster shots of COVID-19 vaccines are currently half doses of the same vaccine used in the first two full shots. The goal is to top up the vaccine formula that reinforces the body’s immune response against the virus and its variants. The Moderna booster authorized by the CDC is a 50-microgram dose, while the first two shots were each 100 micrograms.

    Moderna is also working on a combination shot that contains this year’s flu vaccine and its COVID-19 booster vaccine, but that’s not available right now.

    Moderna’s booster shot is currently half the size of a full dose.

    Safety Of Influenza Vaccine During Pregnancy Or Breastfeeding

    Influenza vaccine is safe to give during any stage of pregnancy or while breastfeeding for both the mother and her baby.86-89 Several systematic reviews have shown no association between influenza vaccination in pregnancy and adverse birth outomes.90,91

    Standard influenza vaccines are currently preferred for use in pregnancy because a large body of evidence supports their safety in pregnant women. While the use of cell-based influenza vaccines in pregnancy has not been assessed, there are no theoretical concerns regarding their safety in pregnant women.

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    Is It Safe To Mix And Match Vaccine And Booster Brands

    Yes. The US Food and Drug Administration has authorized mixing COVID-19 boosters, which in the US means Moderna and Pfizer. Any adult eligible for a booster can get any of the available brands of coronavirus vaccines. If you initially received Johnson & Johnson and it’s been two months or longer since you received the initial dose, you’ll be able to get the Moderna or Pfizer booster. If you received Moderna or Pfizer for your first two shots, you could pick any authorized vaccine available to you, if you qualify and it’s been six months or longer since your second shot.

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