Fluzone should not be administered to individuals who have a prior history of Guillain-Barré Syndrome (GBS) (see ADVERSE REACTIONS section).

If Fluzone vaccine is used in persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy, the expected antibody response may not be obtained.

As with any vaccine, vaccination with Fluzone vaccine may not protect 100% of individuals.

General

Care is to be taken by the health-care provider for the safe and effective use of this vaccine.

Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.

Because intramuscular injection can cause injection site hematoma, Fluzone vaccine should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer Fluzone vaccine in such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.

As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine.

As a precautionary measure, epinephrine injection (1:1000) must be immediately available in case of unexpected anaphylactic or serious allergic reactions.

Influenza virus is remarkable in that minor antigenic changes occur frequently (antigenic drift), whereas a significant antigenic change leading to a pandemic strain (antigenic shift) is unpredictable. It is known that Influenza Virus Vaccine, as now constituted, is not effective against all possible strains of influenza virus. Protection is limited to those strains of virus from which the vaccine is prepared or to closely related strains.

During the course of any febrile respiratory illness or other active infection, use of Influenza Virus Vaccine should be delayed.

Since the likelihood of febrile convulsions is greater in children aged 6 months-35 months, special care should be taken in weighing relative risks and benefits of vaccination.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccine, previous immunization history, current health status (see CONTRAINDICATIONS and WARNINGS sections) and a knowledge of the current literature concerning the use of the vaccine under consideration.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Pregnancy Category C

Animal reproduction studies have not been conducted with Influenza Virus Vaccine. It is not known whether Influenza Virus Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine should be given to a pregnant woman only if clearly needed. For guidance regarding use in pregnant women, see INDICATIONS AND USAGE section.

Pediatric Use

SAFETY AND EFFECTIVENESS OF FLUZONE VACCINE (SUBVIRION) IN INFANTS BELOW THE AGE OF 6 MONTHS HAVE NOT BEEN ESTABLISHED.

ACIP recommends that healthy children aged 6-23 months, and close contacts of children aged 0-23 months, be vaccinated against influenza (see TARGET GROUPS FOR VACCINATION subsection).¹

Data in children as young as 6 months show that protective levels of antibody (hemagglutination inhibition antibody titers ≥ 1:40) can be attained after influenza vaccination, although the antibody responses among children at high risk of influenza-related complications might be lower than among healthy children.¹

In a randomized study among children aged 1-15 years, inactivated influenza vaccine was 77%-91% effective against influenza respiratory illness and was 44%-49%, 74%-76%, and 70%-81% effective against influenza seroconversion among children aged 1-5, 6-10, and 11-15 years respectively.¹

In a randomized, double-blind, placebo-controlled study of the efficacy of Fluzone vaccine against culture positive influenza in healthy children aged 6-24 months was conducted over two seasons.

During the 1999-2000 influenza season, the efficacy of the vaccine against culture-proven influenza in the first cohort was 66% (95% CI 34%-82%). In this year, culture-proven influenza was identified in 15 (5.5%) of 273 children in the vaccine group and 22 (15.9%) of 138 children in the placebo group. During the 2000–2001 season, the efficacy in the second cohort was -7% (95% CI -247% to 67%), however the overall attack rate was 3%, a rate that inhibited obtaining true efficacy.²⁰ In a study using 2 doses of Fluzone vaccine in healthy children aged 6-24 months, the following immunogenicity results were obtained over two consecutive seasons in two different cohorts: ²⁰

TABLE 1 ²⁰ GEOMETRIC MEAN TITER (GMT) AND PERCENTAGE (%) SEROPROTECTED (TITER 1:40 OR GREATER) (N = 31-35)

An analysis of 215,600 children aged < 18 years and 8,476 children aged 6-23 months enrolled in 1 of 5 health maintenance organizations reported no increase in biologically plausible medically attended events during the 2 weeks after inactivated influenza immunization.¹ Between January 1, 1991- January 23, 2003, Vaccine Adverse Events Reporting System (VAERS) received 1,072 reports of adverse events among children < 18 years, including 174 reports of adverse events among children aged 6-23 months. The number of doses given to children during this time period is unknown. The most frequently reported events among children were fever, injection-site reaction, and rash. (See CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE sections.)

Geriatric Use

In a systematic review of adverse events by Sanofi Pasteur Inc. for two previous influenza seasons, there were no differences in reports of adverse events occurring with any distributed lots of Fluzone vaccine for 1999-2001. In addition, there were no observed changes in the number or types of adverse events reported for Fluzone vaccine during 1999-2001 for persons 65 years and older.²¹

There are age-related differences in immune responses to many vaccines. The differences have been reviewed for travel vaccines.²² Lower immunogenicity for influenza vaccines given to elderly persons compared to young adults has also been observed.²¹

In a study of the immunogenicity of Fluzone vaccine in a geriatric population,²¹ the following results were obtained using Fluzone vaccine for 1999-2000:

TABLE 2 ²¹ GEOMETRIC MEAN TITER (GMT) AND PERCENTAGE (%) SEROPROTECTED (TITER 1:40 OR GREATER) (N = 58-62)

A randomized trial among noninstitutionalized persons aged ≥ 60 years reported a vaccine efficacy of 58% against influenza respiratory illness, but indicated that efficacy might be lower among those aged ≥ 70 years. The vaccine can also be effective in preventing secondary complications and reducing the risk for influenza-related hospitalization and death among adults ≥ 65 years with and without high-risk medical conditions (eg, heart disease and diabetes). Among elderly persons living outside of nursing homes or similar chronic-care facilities, influenza vaccine is 30%-70% effective in preventing hospitalization for pneumonia and influenza.¹ (See CLINICAL PHARMACOLOGY section.)

REFERENCES

1. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2004;53: 1-40.

20. Hoberman A, et al. JAMA 2003;290(12):1608-1616.

21. Sanofi Pasteur Inc., Data on File. MKT5720, 1994.

22. Leder K, et al. Clin Infect Dis 2001;33:1553-1566.

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