Fluzone vaccine is indicated for active immunization against influenza disease caused by influenza virus types A and B contained in the vaccine in subjects from 6 months of age and older.

The optimal time to vaccinate is usually during October-November. ACIP recommends that vaccine providers focus their vaccination efforts in October and earlier primarily on persons aged ≥ 50 years, persons aged < 50 years at increased risk for influenza-related complications (including children aged 6-23 months), household contacts of persons at high risk (including out-of-home caregivers and household contacts of children aged 0-23 months), and health-care workers. Vaccination of children aged < 9 years who are receiving vaccine for the first time should also begin in October or earlier because those persons need a booster dose 1 month after the initial dose. Efforts to vaccinate other persons who wish to decrease their risk for influenza infection should begin in November; however, if such persons request vaccination in October, vaccination should not be deferred.¹ After November, many persons who should or want to receive influenza vaccine remain unvaccinated. In addition, substantial amounts of vaccine remained unused during the past four influenza seasons. To improve vaccine coverage, influenza vaccine should continue to be offered in December and throughout the influenza season as long as vaccine supplies are available, even after influenza activity has been documented in the community. In the US, seasonal influenza activity can begin to increase as early as October or November, but influenza activity has not reached peak levels in the majority of recent seasons until late December-early March. Therefore, although the timing of influenza activity can vary by region, vaccine administered after November is likely to be beneficial in the majority of influenza seasons. Adults develop peak antibody protection against influenza infection 2 weeks after vaccination.¹

To avoid missed opportunities for vaccination of persons at high risk for serious complications, such persons should be offered vaccine beginning in September during routine health-care visits or during hospitalizations, if vaccine is available. In facilities housing older persons (eg, nursing homes), vaccination before October typically should be avoided because antibody levels in such persons can begin to decline within a limited time after vaccination.

Persons planning substantial organized vaccination campaigns should consider scheduling these events after mid-October because the availability of vaccine in any location cannot be ensured consistently in the early fall. Scheduling campaigns after mid-October will minimize the need for cancellations because vaccine is unavailable.¹ (For information on vaccination of travelers, see TRAVELERS subsection.)

Dosage recommendations vary according to age group (TABLE 3). Among previously unvaccinated children aged < 9 years, who are receiving influenza vaccine for the first time, two doses administered ≥ 1 month apart are recommended for satisfactory antibody responses. If possible, the second dose should be administered before December. If a child aged < 9 years receiving vaccine for the first time does not receive a second dose of vaccine within the same season, only 1 dose of vaccine should be administered the following season (see TABLE 3). Among adults, studies have indicated limited or no improvement in antibody response when a second dose is administered during the same season. Even when the current influenza vaccine contains ≥ 1 antigen administered in previous years, annual vaccination with the current vaccine is necessary because immunity declines during the year after vaccination. Vaccine prepared for a previous influenza season should not be administered to provide protection for the current season.¹

The intramuscular route is recommended for influenza vaccine (see DOSAGE AND ADMINISTRATION section). Dosage recommendations for the 2007-2008 season are given in Table 3. Guidelines for the use of vaccine among certain patient populations are given below.¹

Influenza vaccine (subvirion) is strongly recommended for any person aged ≥ 6 months who is at increased risk for complications of influenza. In addition, health-care workers and other persons (including household members) in close contact with persons at high risk should be vaccinated to decrease the risk of transmitting influenza to persons at high risk. Influenza vaccine also can be administered to any person aged ≥ 6 months to reduce the chance of becoming infected with influenza.¹ (See TARGET GROUPS FOR VACCINATION subsection.)

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

Target Groups For Vaccination

Persons at Increased Risk for Complications

According to ACIP, vaccination is recommended for the following groups of persons who are at increased risk for complications from influenza:¹

• persons aged ≥ 65 years;
• residents of nursing homes and other chronic-care facilities that house persons of any age who have chronic medical conditions;
• adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma;
• adults and children who have required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus [HIV]);
• children and adolescents (aged 6 months-18 years) who are receiving long-term aspirin therapy and, therefore, might be at risk for developing Reye syndrome after influenza infection;
• women who will be pregnant during the influenza season; and
• children aged 6-23 months.

In 2000, approximately 73 million persons in the US were included in one or more of these target groups, including 35 million persons aged ≥ 65 years; and 12 million adults aged 50-64 years, 18 million adults aged 18-49 years, and 8 million children aged 6 months-17 years with one or more medical conditions that are associated with an increased risk of influenza-related complications.¹

Persons Aged 50 to 64 Years

Vaccination is recommended for persons aged 50-64 years because this group has an increased prevalence of persons with high risk conditions. In 2000, approximately 42 million persons in the US were aged 50-64 years, of whom 12 million (29%) had one or more high-risk medical conditions. Influenza vaccine has been recommended for this entire age group to increase the low vaccination rates among persons in this age group with high-risk conditions. Age-based strategies are more successful in increased vaccine coverage than patient-selection strategies based on medical conditions. Persons aged 50-64 years without high-risk conditions also receive benefit from vaccination in the form of decreased rates of influenza illness, decreased work absenteeism, and decreased need for medical visits and medication, including antibiotics. Further, 50 years is an age when other preventive services begin and when routine assessment of vaccination and other preventive services has been recommended.¹

Also, persons who smoke tobacco products are at increased risk for influenza-related complications and therefore should receive influenza vaccine.^5-7

Persons Who Can Transmit Influenza to Those at High Risk: ¹

Persons who are clinically or subclinically infected can transmit influenza virus to persons at high risk for complications from influenza. Decreasing transmission of influenza from caregivers and household contacts to persons at high risk might reduce influenza-related deaths among persons at high risk. Evidence from two studies indicates that vaccination of health-care personnel is associated with decreased deaths among nursing home patients. Vaccination of health-care personnel and others in close contact with persons at high risk, including household contacts, is recommended. The following groups should be vaccinated:¹

• physicians, nurses, and other personnel in both hospital and outpatient-care settings, including medical emergency response workers (eg, paramedics and emergency medical technicians);
• employees of nursing homes and chronic-care facilities who have contact with patients or residents;
• employees of assisted living and other residences for persons in groups at high risk;
• persons who provide home care to persons in groups at high risk; and
• household contacts (including children) of persons in groups at high risk.

In addition, because children aged 0-23 months are at increased risk for influenza-related hospitalization, vaccination is recommended for their household contacts and out-of-home caretakers, particularly for contacts of children aged 0-5 months, because influenza vaccines have not been approved by the US Food and Drug Administration (FDA) for use among children aged < 6 months.¹

General Population

Physicians should administer influenza vaccine to any person who wishes to reduce the likelihood of becoming ill with influenza (the vaccine can be administered to children aged ≥ 6 months) depending on vaccine availability. Persons who provide essential community services should be considered for vaccination to minimize disruption of essential activities during influenza outbreaks. Students or other persons in institutional settings (eg, those who reside in dormitories) should be encouraged to receive vaccine to minimize the disruption of routine activities during epidemics.¹

Healthy Young Children

Studies indicate that rates of hospitalization are higher among young children than older children when influenza viruses are in circulation. The increased rates of hospitalization are comparable with rates for other groups considered at high risk for influenza-related complications. However, the interpretation of these findings has been confounded by co-circulation of respiratory syncytial viruses, which are a cause of serious respiratory viral illness among children and which frequently circulate during the same time as influenza viruses. Two recent studies have attempted to separate the effects of respiratory syncytial viruses and influenza viruses on rates of hospitalization among children who do not have high-risk conditions. Both studies reported that otherwise healthy children aged < 2 years, and possibly children aged 2-4 years, are at increased risk for influenza-related hospitalization compared with older healthy children. Some studies report that trivalent inactivated influenza vaccine decreases the incidence of influenza-associated otitis media among young children by approximately 30%.¹

Because children aged 6-23 months are at substantially increased risk for influenza-related hospitalizations, ACIP, the American Academy of Pediatrics, and the American Academy of Family Physicians recommends vaccination of all children in this age group. ACIP continues to recommend influenza vaccination of persons aged ≥ 6 months who have high-risk medical conditions.¹

Pregnant Women

Because of the increased risk for influenza-related complications, ACIP recommends that women who will be pregnant during the influenza season should be vaccinated. One study of influenza vaccination of > 2,000 pregnant women demonstrated no adverse fetal effects associated with influenza vaccine.1 (Refer to PREGNANCY CATEGORY C statement.)

The majority of influenza vaccine distributed in the US contains the preservative thimerosal, a mercury-containing compound, but influenza vaccine with a reduced or no thimerosal content is available. Thimerosal has been used in US vaccines since the 1930s. No data or evidence exists of any harm caused by the level of mercury exposure that might occur from influenza vaccination. Because pregnant women are at increased risk for influenza-related complications and because a substantial safety margin has been incorporated into the health guidance values for organic mercury exposure, the benefit of influenza vaccine with standard thimerosal content outweighs the potential risk, if any, for thimerosal.

Breastfeeding Mothers

Influenza vaccine does not adversely affect mothers or their infants who are being breastfed. Breastfeeding does not adversely affect the immune response and is not a contraindication for vaccination.¹

Persons Infected with Human Immunodeficiency Virus (HIV)

Limited information is available regarding the frequency and severity of influenza illness or the benefits of influenza vaccination among persons with HIV infection. However, a retrospective study of young and middle-aged women found that the attributable risk for cardiopulmonary hospitalizations among women with HIV infection was higher during influenza seasons than in the peri-influenza periods. The risk for hospitalization was higher for HIV-infected women than for women with other well-recognized high-risk conditions, including chronic heart and lung diseases. Other reports indicate that influenza symptoms might be prolonged and the risk for complications from influenza increased for certain HIV-infected persons.¹

Influenza vaccination has been demonstrated to produce substantial antibody titers against influenza among vaccinated HIV-infected persons who have minimal acquired immunodeficiency syndrome-related symptoms and high CD4⁺ T-lymphocyte cell counts. A limited, randomized, placebo-controlled trial determined that influenza vaccine was highly effective in preventing symptomatic, laboratory-confirmed influenza infection among HIV-infected persons with a mean of 400 CD4⁺ T-lymphocyte cells/mm³; a limited number of persons with CD4⁺ T-lymphocyte cell counts of < 200 were included in that study. Among persons who have advanced HIV disease and low CD4⁺ T-lymphocyte cell counts, influenza vaccine might not induce protective antibody titers; a second dose of vaccine does not improve the immune response in these persons.¹

One study determined that HIV RNA (ribonucleic acid) levels increased transiently in one HIV-infected patient after influenza infection. Studies have demonstrated a transient (ie, 2-4-week) increase in replication of HIV-1 in the plasma or peripheral blood mononuclear cells of HIV-infected persons after vaccine administration. Other studies using similar laboratory techniques have not documented a substantial increase in replication of HIV. Deterioration of CD4⁺ T-lymphocyte cell counts or progression of HIV disease have not been demonstrated among HIV-infected persons after influenza vaccination compared with unvaccinated persons. Limited information is available concerning the effect of antiretroviral therapy on increases in HIV RNA levels after either natural influenza infection or influenza vaccination. Because influenza can result in serious illness, and because influenza vaccination can result in the production of protective antibody titers, vaccination will benefit HIV-infected patients, including HIV-infected pregnant women.¹

Travelers

The risk of exposure to influenza during travel depends on the time of year and destination. In the tropics, influenza can occur throughout the year. In the temperate regions of the Southern Hemisphere, the majority of influenza activity occurs during April-September. In temperate climate zones of the Northern and Southern Hemispheres, travelers also can be exposed to influenza during the summer, especially when traveling as part of large organized tourist groups (eg, on cruise ships) that include persons from areas of the world where influenza viruses are circulating. Persons at high risk for complications of influenza who were not vaccinated with influenza vaccine during the preceding fall or winter should consider receiving influenza vaccine before travel if they plan to:¹

• travel to the tropics;
• travel with organized tourist groups at any time of year; or
• travel to the Southern Hemisphere during April-September.

No information is available regarding the benefits of revaccinating persons before summer travel who were already vaccinated in the preceding fall. Persons at high risk who received the previous season's vaccine before travel should be revaccinated with the current vaccine in the following fall or winter. Persons aged ≥ 50 years and others at high risk might want to consult with their physicians before embarking on travel during the summer to discuss the symptoms and risks for influenza and the advisability of carrying antiviral medications for either prophylaxis or treatment of influenza.¹

Concomitant Administration N With Other Vaccines

CONCURRENT USE WITH PNEUMOCOCCAL VACCINE. Influenza vaccine has been shown in clinical studies to be acceptable for concurrent use with pneumococcal vaccine using separate syringes at different sites.⁸ Although Influenza Virus Vaccine is recommended for annual use, the pneumococcal vaccine is not.^9,10,11 When indicated, pneumococcal vaccine should be administered to patients who are uncertain regarding their vaccination history. No studies regarding the concomitant administration of inactivated influenza vaccine and other childhood vaccines have been conducted. Children at high risk for influenza-related complications, including those aged 6-23 months, can receive influenza vaccine at the same time they receive other routine vaccinations.¹¹

Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

To help avoid HIV (AIDS), HBV, (Hepatitis) and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or such action is required by a specific medical procedure.

The vial should be shaken well before withdrawing each dose.

The prefilled syringe should be shaken well before administering each dose. The 0.25 mL prefilled syringe is preferred for use when 0.25 mL is indicated for children.

Do NOT inject intravenously.

Injections of Influenza Virus Vaccine should be administered intramuscularly, preferably in the region of the deltoid muscle, in adults and older children. A needle length of ≥ 1 inch is preferred for these age groups because needles < 1 inch might be of insufficient length to penetrate muscle tissue in certain adults and older children. Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

Infants and young children should be vaccinated in the anterolateral aspect of the thigh. ACIP recommends a needle length of 7/8-1 inch for children < 12 months for intramuscular vaccination into the anterolateral thigh. When injecting into the deltoid muscle among children with adequate deltoid muscle mass, a needle length of 7/8-1-1/4 inches is recommended.¹

Influenza vaccine should be offered beginning in September (see INDICATIONS AND USAGE section).

Children < 9 years who have not previously been vaccinated should receive two doses of vaccine ≥ 1 month apart to maximize the likelihood of a satisfactory antibody response to all three vaccine antigens. If possible, the second dose should be administered before December.¹

Fluzone vaccine (Subvirion) is to be used for persons 6 months of age and older. Fluzone vaccine (Subvirion) is NOT approved for infants under 6 months of age. The dosage is as follows:

TABLE 3 ¹ Influenza Vaccine Dosage by Age Group 2007-2008 Season

Syringe, without needle, 0.25 mL (contains NO preservative) (10 per package) Shake syringe well before administering. - Product No. 49281-006-25

Syringe, without needle, 0.5 mL (contains NO preservative) (10 per package) Shake syringe well before administering. - Product No. 49281-006-50

Vial, 0.5 mL (contains NO preservative) (10 per package) Shake vial well before administering. - Product No. 49281-006-10

Vial, 5 mL (contains preservative) for administration with needle and syringe or sterile disposable unit. Shake vial well before withdrawing each dose. - Product No. 49281-378-15

Storage

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

REFERENCES

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

5. Mulloy E. Ir Med J Vol 89 (6): 202, 204, 1996.

6. Zimmerman RK, et al. Am Fam Physician 51 (4): 859-867, 1995.

7. Rothbarth PH, et al. Am J Respir Crit Care Med 151: 1682-1686, 1995.

8. Honkanen P, et al. Arch Intern Med 156: 205-208, 1996.

9. Grilli G, et al. Eur J Epidemiol 13: 287-291, 1997.

10. DeStefano F, et al. JAMA 247: 2551-2554, 1982.

11. CDC. MMWR 2003;52:1-33.

Manufactured by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA Product information as of May 2007. FDA Rev date: 7/13/2007

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