Flumist (Nasal Influenza Virus Vaccine)

Flumist is a live attenuated quadrivalent influenza vaccination that is offered as a nasal spray for the prevention of seasonal influenza.

Flumist (Influenza virus vaccine) Uses:

  • Influenza disease prevention:

    • US labeling:

      • Everyone over the age of six who does not have any vaccination-related contraindications should receive an annual dose of the seasonal influenza vaccine, according to the recommendations of the Advisory Committee on Immunization Practices (ACIP).

      • For the influenza season of 2019–2020, healthy individuals between the ages of 2 and 49 may elect to get the live attenuated influenza vaccination. (LAIV4).

      • Vaccination against influenza viruses subtypes A and B, which are present in the vaccine, for people between the ages of 2 and 49

      • The American Academy of Pediatrics (AAP) and the American College of Infectious Diseases (ACIP) don't particularly recommend a preference for an influenza vaccination when age and risk factors are taken into account.

    • Canadian labeling:

      • The vaccination for persons between the ages of 2 and 59 includes protection against influenza illness brought on by influenza virus subtypes A and B.
      • The National Advisory Committee on Immunization (NACI) of Canada (NACI 2019) offers the suggestions listed below:
        • Healthy, non-pregnant people between the ages of 2 and 59 can have the seasonal live, attenuated influenza vaccine (LAIV). (nasal mist).
        • Everyone above the age of six months who has no vaccination-related contraindications needs to have one dose of the seasonal influenza vaccine every year.
        • Take into account your choices for the influenza vaccine:
          • Individuals If a quadrivalent inactivated influenza vaccination (IIV4) is not available, a trivalent inactivated influenza vaccine (IIV3) is preferred for kids between the ages of 6 and 23 months.
          • Individuals LAIV or IIV4 are given preference for ages 2 to 17. (IIV3 may be considered if neither IIV4 nor LAIV are available)
          • Those who are younger than 65: At the level of public health programmes, any IIV3 or IIV4 vaccine that is presently in use may be used, albeit IIV3-HD (high dose) is recommended to IIV3-SD (standard dose).
          • Health care professionals: IIV4 or IIV3 are indicated instead of LAIV in such individuals.
  • The following groups are among the immunisation targets for times when vaccine supplies are low (those who are more prone to have complications from influenza infection and their close contacts):
    • Note: Exclusively use LAIV if applicable:
      • Everyone who is born and every kid between the ages of 6 and 59
      • During the influenza season, women who are or will be pregnant
      • Individuals with chronic lung conditions, such as asthma, or CVS diseases, with the exception of isolated hypertension, renal issues, hepatic issues, neurologic issues, or metabolic conditions, such as diabetic mellitus
      • Individuals under the age of 50
      • Babies, kids, and teenagers between the ages of 6 months and 18 years who are taking aspirin long-term for whatever cause are susceptible to developing Reye syndrome after influenza.
      • Those who have a weakened immune system for whatever reason 
      • Native Americans of America and Alaska
      • Students in these disciplines as well as health care workers who are not actively involved in patient care but may come into touch with patients and be exposed to infectious germs (eg, clerical, housekeeping, volunteers)
      • Those who live in nursing homes, retirement communities, and other facilities providing long-term care
      • Members of the family who are more likely to experience complications from an influenza infection include children, those who care for persons with medical conditions, and caregivers.
      • The NACI also advises vaccination for people who have neurologic or neurodevelopmental conditions like neuromuscular, neurovascular, or neurodegenerative diseases, seizure disorders (including febrile seizures in infants and isolated developmental delay), and seizure disorders, but not for people who suffer from migraines or who have psychiatric problems unrelated to neurological issues.
      • Children, people over the age of 50, and those caring for newborns, infants, and children under five, especially those under six months old, are considered household contacts.
      • (BMI > 40) excessively obese

Influenza virus vaccine dose in adults:

  • Seasons for the flu vary in duration and timing from year to year.
  • In order to get the best protection prior to the start of influenza activity in the community and for the length of it, vaccination should often start in September and October (in the United States).
  • Early influenza vaccination (in July or August) has been linked to inadequate protection prior to the end of a flu season, especially in elderly adults.
  • As long as the shot is available, vaccination should continue throughout the influenza season.

Flumist Intranasal dose for Influenza Immunization:

  • Usage in the US:

    • adults 50 years of age or older: 

      • (2 mL/dose, 0.1 mL/nasal) (1 dose per season).
  • Labeling in Canada:

    • Adults under 59 years:

      • 2 mL/dose (0.1 mL per nostril) (1 dose per season).
  • Not recommended for patients under the age of 50 or 60 (according to US labeling) (Canadian labeling).

Influenza virus vaccine dose in children:

Note:

  • In addition to LAIV4, children under the age of six months may get inactivated influenza shots, and those over the age of eighteen may receive the recombinant influenza vaccine (RIV). The ACIP and AAP do not favour any specific influenza vaccination product and recommend using any product that is age- and weight-appropriate.
  • Flu seasons vary in length and timing from year to year.
  • The live attenuated influenza vaccine is an alternative for healthy people between the ages of 2 and 49 who will be exposed to the influenza virus during the 2019–2020 season (LAIV4).
  • Early influenza vaccination (in July or August) has been linked to inadequate protection before the conclusion of a flu season, especially in older individuals.
  • As long as the shot is still available, the immunisation campaign should continue throughout the influenza season.
  • The ACIP accepts dosages given four days before the minimum interval or age as valid; however, local or state limitations may take precedence over this time period.
  • Immunization should be administered to ensure the greatest level of protection both before and during the duration of influenza activity.

Flumist dose for annual Influenza Immunization:

  • Children 2 to 8 years:

    • Intranasal: 1 or 2 doses every season, totalling 0.2 mL per dose (1/2 dose per nostril). Vaccination history affects the number of doses needed each flu season; consider the following factors:
      • One dose:

        • It is not necessary to provide the dosage during the current flu season or the seasons that follow if the patient has already received two doses or more of the trivalent or quadrivalent influenza vaccine before the start of the current flu season on July 1.
      • two doses spaced around four weeks apart: If any of the following:

        • If the vaccination status is not known.
        • A person who received no more than one dose of the quadrivalent or trivalent influenza vaccine before the current flu season began (including no previous vaccination).

Note:

  • two doses spaced around four weeks apart: If any of the following: Two doses should be administered if the kid becomes 9 years old between the first and second doses.
  • Under-9-year-olds and adolescents:

    • Intranasal: One dose per season, totalling 0.2 mL (half dose per nostril).

 

Pregnancy Risk Category: D

  • Pregnant women are advised not to get live attenuated influenza vaccinations, according to the Advisory Committee on Immunization Practices.
  • After maternal nasal administration, the vaccine is not systemically absorbed and should not be exposed to the fetus.

Influenza virus vaccine use during breastfeeding:

  • After maternal nasal administration, the vaccine is not systemically absorbed and is not expected in breast milk.

 

Flumist Dose in Kidney Disease:

  • There are no dosage adjustments provided in the drug maker's labeling.

 

Flumist Dose in Liver disease:

  • There are no dosage adjustments provided in the drug maker's labeling.

 

  • Frequency of events reported within 10 days.

Common Side Effects of Flumist (Influenza virus vaccine):

  • Gastrointestinal:

    • Sore Throat
    • Decreased Appetite
    • Abdominal Pain
  • Neuromuscular & Skeletal:

    • Fatigue
    • Weakness
    • Myalgia
  • Respiratory:

    • Nasal Congestion
    • Rhinorrhea
    • Cough
  • Central nervous system:

    • Headache
    • Irritability
    • Lethargy

Less Common Side Effects of Flumist (Influenza virus vaccine):

  • Central nervous system:

    • Chills
  • Otic:

    • Otitis media
  • Respiratory:

    • Wheezing
    • Sinusitis
    • Sneezing
  • Miscellaneous:

    • Fever

 

Contraindications to Flumist (Influenza virus vaccine):

  • Allergy to egg protein, any vaccine component, or a history of influenza vaccination
  • Due to the possibility of acquiring Reye syndrome when taking aspirin and contracting wild-type influenza, children and adolescents (2–17 years of age) get aspirin treatment or aspirin-containing medicines.

Notice:

  • According to the Canadian National Advisory Committee on Immunization and the Advisory Committee on Immunization Practices, an allergy to  eggs is not a deterrent to receiving the influenza vaccination.
  • The ACIP considers the following contraindications.
    • Children between the ages of 2-4 who have recently had asthma or wheezing.
    • Disorders that compromise immunity (such as HIV or immunosuppressive medication);
    • Interactions with critically ill patients that require a safe atmosphere as well as their relatives
    • Taking antiviral medications for the flu within two days after giving birth (CDC/ACIP, Grosskopf 2019).

The NACI advises against delivering LAIV to ACIP if there are any contraindications as well:

  • 24 months old
  • Asthma attack
  • Within the seven days prior to vaccination, wheezing requires medical treatment or is active.

Warnings and precautions

  • Anaphylactoid reactions and hypersensitivity reactions

    • During vaccination, immediate treatment should be provided for hypersensitivity reactions and anaphylactoid reactions (epinephrine 1mg/mL).
  • Acute illness:

    • People who are suffering from severe or minor acute diseases should be placed on hold. Patients who are experiencing a moderate acute sickness, fever or not, shouldn't be kept waiting.
    • The degree of the symptoms and the underlying reason will determine whether or not a vaccine should be administered.
  • Wheezing and asthma:

    • Clinical studies showed that the administration increased wheezing and hospital admissions in children less than 24 months. The use of nasal spray is not recommended for this age range.
    • The live influenza vaccination (LAIV) is contraindicated in children ages 2 to 4 who have experienced wheezing episodes or asthma attacks in the preceding year as well as anyone with chronic respiratory disorders, according to the Advisory Committee on Immunization Practices (ACIP) (including asthma).
    • Patients over 5 years old with asthma should be cautious.
    • People with severe asthma, active wheezing, or wheezing that required medical attention within the last seven days shouldn't receive LAIV, according to the Canadian National Advisory Committee on Immunization.
    • Children under 5 years old with a history of recurrent wheezing are at greater risk. As well as people with asthma, the risk of wheezing after vaccinations is higher in those with asthma.
    • Patients with severe asthma or wheezing were not included in clinical trials.
  • Influenza complications can be caused by medical conditions

    • It has not been shown to be safe to provide LAIV to people who have susceptible medical conditions such as diabetes, chronic pulmonary, cardiovascular, isolated hypertension, or renal, hepatic, or neurological issues.
    • Take care.
  • Guillain-Barre syndrome:

    • Guillain Barre syndrome (GBS) patients should use caution.
    • Limited evidence suggests that the advantages of vaccination may outweigh any risks for those with a history of GBS who are more likely to have serious complications from influenza.
    • The ACIP recommends vaccination for everyone who has a history of GBS, has a low risk of developing serious influenza complications, and has seen GBS symptoms within six weeks after having a previous vaccination.
    • The prevalence of GBS with immunizations is lower than with influenza infection, according to recent research on patients who received the trivalent inactivated flu vaccine (IIV3) and the monovalent H1N1 influenza vaccine.
    • Patients who have had GBS in the past are more likely to have it than those who have not.
  • Congestion of the nasal passages:

    • If you have nasal congestion that may prevent the delivery of the vaccine, use another flu vaccine or delay immunization with LAIV.

Influenza Virus Vaccine (LAIV4) (live attenuated): Drug Interactions:

Risk Factor C (Monitor therapy)

Vaccines (Live)

May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 weeks later.

Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Rotavirus Vaccine.

Risk Factor D (Consider therapy modification)

Antiviral Agents (Influenza A and B)

may reduce the effectiveness of the live/attenuated influenza virus vaccination in illness prevention. Management: Refrain from using antiviral medications that are intended to treat influenza during the 48-hour window before and the two weeks following the injection of live influenza vaccination.

Axicabtagene Ciloleucel

May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Axicabtagene Ciloleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for at least 6 weeks prior to initiation of lymphodepleting therapy, during axicabtagene ciloleucel infusion, and after treatment until full immune recovery is achieved.

AzaTHIOprine

May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for the administration of the zoster vaccine. Higher doses of azathioprine should be avoided.

Corticosteroids (Systemic)

May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided.

Dimethyl Fumarate

May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live).

Management: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this.

Leflunomide

May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live).

Management: The ACIP guidelines state that live attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide.

Mercaptopurine

May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live).

Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for the administration of the zoster vaccine. Higher doses of mercaptopurine should be avoided.

Methotrexate

May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live).

Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided.

Tisagenlecleucel

May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Tisagenlecleucel may diminish the therapeutic effect of Vaccines (Live).

Management: Avoid live virus vaccines for two weeks prior to initiation of lympho-depleting therapy, during tisagenlecleucel infusion, and after treatment until full immune recovery is achieved.

Tuberculin Tests

Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine.

Risk Factor X (Avoid combination)

Belimumab

May enhance the adverse/toxic effect of Vaccines (Live).

Daclizumab

May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live).

Dupilumab

May enhance the adverse/toxic effect of Vaccines (Live).

Fingolimod

May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live).

Guselkumab

May enhance the adverse/toxic effect of Vaccines (Live).

Immunosuppressants

May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live).

Management: Avoid the use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants.

Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic).

Ocrelizumab

May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live).

Risankizumab

May enhance the adverse/toxic effect of Vaccines (Live).

Salicylates

The harmful/toxic effects of salicylates may be exacerbated by live/attenuated influenza virus vaccinations. Particularly, Reye's syndrome could happen.

Tildrakizumab

May enhance the adverse/toxic effect of Vaccines (Live). The risk of contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live).

Venetoclax

May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid the use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment.

How to administer Flumist (Influenza virus vaccine)?

  • Only to be administered intravenously; do not inject.
  • Each nostril receives 0.1 mL of the whole dose, which is administered while the patient is standing up.
  • A dose divider clip set up allows for the injection of 0.1 ml into each nostril.
  • To administer the dose, insert the sprayer's tip inside the nose and quickly depress the plunger.
  • Repeat into the opposite nostril after removing the dose divider clip.
  • When receiving treatment, the patient may breathe normally.
  • It is unnecessary to repeat the dose if the recipient sneezes or coughs after receiving it.
  • If there is nasal congestion, which could interfere with the vaccine's delivery, postpone vaccination or use an alternative influenza vaccine.
  • US law mandates that the date the vaccine was administered, the vaccine maker's name, the lot number of the vaccine, the name, title, and address of the person who administered the vaccine, as well as proof of the vaccine information statement, all need to be included in the patient's permanent medical record (VIS; date on VIS, and date administered to the patient).

Mechanism of action of Flumist (Influenza virus vaccine):

  • Live, attenuated viruses that can infect and spread inside nasopharyngeal cells are present in the vaccination.
  • Inducing specific antibodies will help you develop immunity to the seasonal influenza virus.
  • You cannot use preparations from previous seasons.

The onset of action:

  • Within 2 weeks, most adults have developed antibody protection.

Time:

  • The rate at which vaccine effectiveness decreases depends on the subtype of the virus, patient age, and other factors.

Distribution:

  • Following nasal delivery, vaccinations are primarily dispersed in the nasal cavity (about 90%), stomach (about 3%), brain (about 2%), and lung (about 2%). (0.4 percent ).

 

Influenza vaccines sold internationally:

  • FluMist Quadrivalent
  • FluMist

Influenza virus vaccine Brand Names in Pakistan:

Influenza Vaccine Inj 15 mcg/0.5ml

Agrippal-S1 Novartis Pharma (Pak) Ltd
Fluarix Glaxosmithkline
Vaxigrip Sanofi Aventis (Pakistan) Ltd.

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