FLUVIRIN® is indicated for immunization against the influenza virus strains contained in the vaccine for use in the United States for persons of 4 years of age and older. Even when the current influenza vaccine contains one or more antigens administered in previous years, annual vaccination with the current vaccine is necessary because immunity declines in the year following vaccination.¹ Vaccine prepared for a previous influenza season should not be administered to provide protection for the current season.¹

Target Groups For Vaccination

Persons at increased risk for complications

Vaccination with inactivated influenza vaccine is recommended for the following persons who are at increased risk for complications from influenza (see PRECAUTIONS, Pediatri Use, Geriatric Use).

1.  Persons aged ≥ 65 years.¹
2.  Residents of nursing homes and other chronic-care facilities that house persons of any age who have chronic medical conditions.¹
3.  Adults and children who have chronic disorders of the pulmonary or cardiovascular systems, including asthma.¹
4.  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]).¹
5.  Children and adolescents (aged 6 months to 18 years) who are receiving long-term aspirin therapy and therefore might be at risk for experiencing Reye syndrome after influenza infection.¹ Note, FLUVIRIN® is not indicated for use in children under 4 years of age.
6.  Women who will be pregnant during the influenza season.¹ Refer to IMMUNIZATION OF OTHER GROUPS for use of this product in pregnant women.

In 2000, approximately 73 million persons in the United States 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 for influenza-related complications.¹

Persons aged 50-64 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 United States 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 increasing 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

Persons who can transmit influenza to those at high risk

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 care-givers 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. Health-care workers should be vaccinated against influenza annually. Facilities that employ health-care workers are strongly encouraged to provide vaccine to workers by using approaches that maximize immunization rates. This will protect health-care workers, their patients, and communities, and will improve prevention, patient safety, and reduce disease burden. Health-care workers' influenza immunization rates should be regularly measured and reported. Although rates of health-care worker vaccination are typically < 40%, with moderate effort, organized campaigns can attain higher rates of vaccination among this population.¹ The following groups should be vaccinated:¹

1.  Physicians, nurses, and other personnel in both hospital and outpatient-care settings, including medical emergency response workers (e.g. paramedics and emergency medical technicians).¹
2.  Employees of nursing homes and chronic-care facilities who have contact with patients or residents.¹
3.  Employees of assisted living and other residences for persons in groups at high-risk.¹
4.  Persons who provide home care to persons in groups at high-risk.¹
5.  Household contacts (including children) of persons in groups at high risk.¹

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 caregivers, particularly for contacts of children aged 0-5 months because influenza vaccines have not been approved by the U.S. Food and Drug Administration (FDA) for use among children aged < 6 months.¹

Immunization Of Other Groups

General population

In addition to the groups for which annual influenza vaccination is recommended, physicians should administer influenza vaccine to any person who wishes to reduce the likelihood of becoming ill with influenza. See INDICATIONS AND USAGE, and WARNINGS sections. 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 (e.g., those who reside in dormitories) should be encouraged to receive vaccine to minimize the disruption of routine activities during epidemics.¹

Pregnant women

Influenza-associated excess deaths among pregnant women were documented during the pandemics of 1918-1919 and 1957-1958. Case reports and limited studies also indicate that pregnancy can increase the risk for serious medical complications of influenza. An increased risk might result from increases in heart rate, stroke volume and oxygen consumption; decreases in lung capacity; and changes in immunologic function during pregnancy. A study of the effect of influenza during 17 interpandemic influenza seasons demonstrated that the relative risk for hospitalization for selected cardiorespiratory conditions among pregnant women enrolled in Medicaid increased from 1.4 during weeks 14-20 of gestation to 4.7 during weeks 37-42 in comparison with women who were 1-6 months postpartum. Women in their third trimester of pregnancy were hospitalized at a rate (i.e., 250 per 100,000 pregnant women) comparable with that of nonpregnant women who had high-risk medical conditions. Researchers estimated that an average of 1-2 hospitalizations can be prevented for every 1,000 pregnant women vaccinated. ¹

Because of the increased risk for influenza-related complications, women who will be pregnant during the influenza season should be vaccinated.1 Vaccination can occur in any trimester.¹

One study of influenza vaccination of > 2,000 pregnant women demonstrated no adverse fetal effects associated with influenza vaccine.¹

The majority of influenza vaccine distributed in the United States contains thimerosal, a mercury-containingcompound, as a preservative. Thimerosal has been used in U.S. vaccines since the 1930s. No scientificallyconclusive evidence exists of harm from exposure to thimerosal preservative-containing vaccine.¹ The risks ofsevere illness from influenza infection are elevated among pregnant women and young children, and bothgroups benefit from vaccination by preventing illness and death from influenza.¹

Controlled studies on FLUVIRIN® have not been conducted to demonstrate safety in pregnant women.

The clinical judgment of the attending physician should prevail at all times in determining whether to administer the vaccine to a pregnant woman (see PRECAUTIONS, Use in Pregnancy).

Breast feeding mothers

Influenza vaccine does not affect the safety of mothers who are breastfeeding or their infants. 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 human immunodeficiency virus (HIV) infection. However, a retrospective study of young and middle-aged women enrolled in Tennessee's Medicaid program determined that the attributable risk for cardiopulmonary hospitalizations among women with HIV infection was higher during influenza seasons than during 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. Another study estimated that the risk for influenza-related death was 9.4-14.6 per 10,000 persons with acquired immunodeficiency syndrome (AIDS) compared with 0.09-0.10 per 10,000 among all persons aged 25-54 years and 6.4-7.0 per 10,000 among persons aged ≥ 65 years. 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 AIDS-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. A nonrandomized study among HIV-infected persons determined that influenza vaccination was most effective among persons with > 100 CD4+ cells and among those with < 30,000 viral copies of HIV type 1/mL.¹ 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 person after influenza infection. Studies have demonstrated a transient (i.e., 2- to 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 the 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 persons, including HIV-infected pregnant women.¹

Travelers

The risk for 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 (e.g., 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 a) travel to the tropics; b) travel with organized tourist groups at any time of year; or c) 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 the following fall or winter. Persons aged ≥ 50 years and others at high risk should consult with their physicians before embarking on travel during the summer to discuss the symptoms and risks for influenza. 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.¹ 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. Among the Tennessee Medicaid population during 1973-1993, healthy children aged 6 months- < 3 years had rates of influenza-associated hospitalization comparable with or higher than rates among children aged 3-14 years with high risk conditions.¹ Another Tennessee study reported a hospitalization rate per year of 3-4 per 1,000 healthy children aged < 2 years for laboratory confirmed influenza.¹

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

The current inactivated influenza vaccine is not approved by FDA for use among children aged < 6 months, the pediatric group at greatest risk for influenza-related complications.¹ Vaccinating their household contacts and out-of-home caregivers might decrease the probability of influenza infection among these children.

Persons Who Should Not Be Vaccinated

Inactivated influenza vaccine should not be administered to persons known to have anaphylactic hypersensitivity to eggs or to other components of the influenza vaccine without first consulting a physician¹ (see CONTRAINDICATIONS, WARNINGS, ADVERSE REACTIONS - Systemic Reactions). Prophylactic use of antiviral agents is an option for preventing influenza among such persons.¹ However, persons who have a history of anaphylactic hypersensitivity to vaccine components but who are also at high risk for complications from influenza can benefit from vaccine after appropriate allergy evaluation and desensitization.¹ Persons with acute febrile illness usually should not be vaccinated until their symptoms have abated. However, minor illnesses with or without fever do not contraindicate the use of influenza vaccine, particularly among children with mild upper respiratory tract infection or allergic rhinitis.¹

TIMING OF ANNUAL INFLUENZA VACCINATION

ACIP recommends that vaccine campaigns conducted in October should focus their efforts primarily on persons at increased risk for influenza complications and their contacts, including health-care workers. Campaigns conducted in November and later should continue to vaccinate persons at high risk and their contacts, but also vaccinate other persons who wish to decrease their risk for influenza infection. Vaccination efforts for all groups should continue into December and beyond.¹

Vaccination in October and November

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, 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.¹ 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.¹ 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.

Vaccination in December and Later

After November, many persons who should, or want to receive influenza vaccine remain unvaccinated. In addition, substantial amounts of vaccine have remained unused during three of 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.¹ In the United States, seasonal 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

Vaccination Before October

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.¹ In facilities housing older persons (e.g., 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.¹ In addition, children aged < 9 years who have not been previously vaccinated and who need 2 doses before the start of the influenza season can receive their first dose in September or earlier.¹

Timing of Organized Vaccination Campaigns

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 early fall.¹ Scheduling campaigns after mid-October will minimize the need for cancellations because vaccine is unavailable. Campaigns conducted before November should focus efforts on vaccination of persons aged ≥ 50 years, persons aged < 50 years at increased risk for influenza-related complications, health-care workers, and household contacts of persons at high-risk (including children aged 0-23 months) to the extent feasible.¹

For Intramuscular Use Only. Shake well before withdrawing each dose. DO NOT INJECT INTRAVENOUSLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION).

Vaccine prepared for a previous influenza season should not be administered to provide protection for the current season.

Although Influenza Virus Vaccine often contains one or more antigens used in previous years, immunity declines during the year following immunization. Therefore, a history of immunization in any previous year with a vaccine containing one or more antigens included in the current vaccine does NOT preclude the need for reimmunization for the 2007-2008 influenza season in order to provide optimal protection.

See TIMING OF ANNUAL INFLUENZA VACCINATION for information regarding the optimal time of administration of this vaccine.
During recent decades, data on influenza vaccine immunogenicity and side effects have generally been obtained when vaccine has been administered intramuscularly. Because recent influenza vaccines have not been adequately evaluated when administered by other routes, the intramuscular route is recommended. Adults and older children should be vaccinated in the deltoid muscle. A needle length =1 inches can be considered for these age groups because needles < 1 inch might be of insufficient length to penetrate muscle tissue in certain adults and older children.¹ Infants and young children should be vaccinated in the anterolateral aspect of the thigh.¹ When injecting into the deltoid muscle among children with adequate deltoid muscle mass, a needle length of 7/8- 1 1/4inches is recommended.¹

Before immunization, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel.

Dosage recommendations vary according to age group, as follows:

Among previously unvaccinated children aged < 9 years, 2 doses administered at least 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 one dose of vaccine should be administered the following season. Two doses are not required at that time. Among adults, studies have indicated little or no improvement in antibody response when a second dose is administered during the same season.¹ Because of their decreased potential for causing febrile reactions, only split-virus vaccines should be used for children aged < 13 years. The vaccines might be labelled as "split", "subvirion", or "purified-surface-antigen"vaccine.¹
0.25mL doses should not be used.

Novartis Vaccines and Diagnostics Limited does not recommend the use of needleless injectors for administration of FLUVIRIN®.

Simultaneous administration of other vaccines, including childhood vaccines

Inactivated influenza vaccine coadministration has been evaluated systematically only among adults with pneumococcal polysaccharide vaccine.¹ No studies regarding the simultaneous administration of inactivated influenza vaccine and other childhood vaccines have been conducted. However, inactivated vaccines usually do not interfere with the immune response to other inactivated or live vaccines.¹ However, physicians may prefer not to administer influenza vaccine within 3 days of administration of pertussis containing vaccines.

NDC 66521-110-10; 5 mL multi dose vial (24.5 mcg mercury per 0.5 mL dose).

STORAGE

DO NOT FREEZE. STORE REFRIGERATED, AWAY FROM FREEZER COMPARTMENT, AT 2°C to 8°C (36°F to 46°F).

FROZEN/PREVIOUSLY FROZEN PRODUCT SHOULD NOT BE USED.

Vaccine must be transported under refrigeration temperatures.

REFERENCES

1. Centers for Disease Control and Prevention. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2004;53 (Early Release):[1-40].

IMPORTANT INFORMATION for Group Immunization Programs: If this vaccine is to be used in an immunization program sponsored by any organization WHERE A TRADITIONAL PHYSICIAN/PATIENT RELATIONSHIP DOES NOT EXIST, each recipient (or legal guardian) must be made aware of the benefits and risks of immunization, and informed consent should be obtained from the recipient (or legal guardian) before immunization. Risks of immunization are summarized in the current labeling. PLEASE CONTACT CDC or your local State Department of Health to obtain Important Information about Influenza and a sample Influenza Consent Form.

FLUVIRIN is a registered trademark of Novartis Vaccines and Diagnostics Limited. Manufactured by: Novartis Vaccines and Diagnostics Limited Speke, Liverpool, UK. An affiliate of:
Novartis Vaccines and Diagnostics, Inc. 4560 Horton Street Emeryville, California 94608-2916. USA. 1-800-244-7668. REV: 04-2007. FDA rev date: 7/24/2007

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