FLUVIRAL S/F®

IAF BioVac

Whole-Virion and Split-Virion Influenza Virus Vaccine, Inactivated

Influenza Prophylaxis

Description: Fluviral S/F is a trivalent, inactivated, whole-virion, influenza vaccine prepared from virus grown in the allantoic cavity of embryonated hen's eggs. The viruses are inactivated with formaldehyde and purified by centrifugation. The split-virion vaccine is prepared by disruption of the virus with sodium deoxycholate.

Indications And Clinical Uses: For the active immunization of people in the following groups: 1. Adults and children with: chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) severe enough to require regular medical follow-up or hospital care; other chronic conditions such as diabetes and other metabolic diseases, cancer, immunodeficiency (including HIV infection) or immunosuppression, renal disease and anemia.

Chronic cardiac and pulmonary disorders in persons over the age of 45 are by far the most important risk factors for influenza-related mortality.

2. Residents of nursing homes and other chronic care facilities: Such residents generally have one or more medical conditions outlined in group 1. In addition, their institutional environment may promote spread of the disease. Recent studies have shown that the use of vaccine in this setting will decrease occurence of illness, and has an even greater impact in reducing hospitalization, pneumonia and death.

3. Geriatrics: Persons over 65 years of age: The risk of severe morbidity and mortality related to influenza is moderately increased in healthy persons over 65 years of age but is not nearly as great as in persons with chronic underlying disease.

4. Health-care personnel who have extensive contact with individuals in the high-risk groups 1 to 3 above.

The potential for introducing influenza to persons in the high-risk groups outlined above, particularly those in institutions, should be reduced through vaccination programs targeted in health-care personnel.

5. Children and adolescents (aged 6 months to 18 years) treated for long periods with ASA: Treatment with ASA for long periods might increase the risk of Reye's Syndrome after influenza infection.

6. Household contacts (including children) of individuals at risk: Because low antibody responses to influenza vaccine may occur in some individuals at high risk (e.g. the elderly, HIV infected, and transplant recipients), this strategy may reduce the chances that these patients will be exposed to influenza.

Other persons who provide essential community services may be considered for vaccination programs to minimize disruption of such services in severe epidemics. Influenza vaccine may also be administered to those persons who wish to reduce their chances of acquiring infection.

Pregnancy: The same criteria apply to the vaccination of pregnant women as to other subjects. There is no evidence that influenza vaccine presents any danger whatsoever to the mother or the fetus.

Fluviral S/F can be administered at the same time as (but in a different site from) the pneumococcal vaccine without any deleterious effect on the immune response to either.

Contra-Indications: Fluviral S/F should not be given to subjects with an acute respiratory infection or with any other active infection or serious febrile illness. On the other hand, a minor indisposition such as a mild infection of the upper respiratory tract is not necessarily a contraindication to vaccination.

Allergic reactions are extremely rare and usually attributable to extreme sensitivity to certain components of the vaccine, probably to trace amounts of residual egg protein. Vaccination is not recommended for subjects who develop anaphylactic type reactions when they eat eggs (urticaria, edema of the mouth and throat, difficulty in breathing, hypotension and shock). Subjects whose allergy to eggs is not of the anaphylactic type, as well as those who are allergic to chicken and to feathers may be vaccinated.

Do not administer this vaccine to individuals known to be sensitive to thimerosal or gelatin.

Manufacturers' Warnings In Clinical States: It is possible that the normal immune response following influenza vaccination may not develop in subjects undergoing immunosuppressive therapy.

Precautions: Sterile epinephrine solution 1:1 000 should always be readily available in case an acute anaphylactic reaction should occur.

Increase of serum theophylline to toxic levels following the administration of influenza vaccine has been recorded in individuals who take oral theophylline as a maintenance therapy. Some doctors recommended a cessation of theophylline or a reduction in dose for 24 hours following vaccination.

The administration of influenza vaccine may also delay the hepatic metabolism of other medications such as oral anticoagulants.

Pregnancy: There is no evidence that the influenza vaccine presents any danger whatsoever to the mother or to the fetus. Administering the vaccine after the first trimester is a reasonable precaution to minimize any concern over the theoretical risk of teratogenicity. However, it is undesirable to delay vaccination of pregnant women who have high-risk conditions and who will still be in the first trimester of pregnancy when the influenza season begins.

Children: Use of the vaccine in infants under 6 months of age has not yet been evaluated and therefore is not recommended.

Information for the Patient: Patients should be informed of the most common side effects: Local reactions: Soreness and redness at the injection site that may last for up to 2 days. Systemic reactions: fever, headache, myalgia. These reactions begin 6 to 12 hours after vaccination and can persist for 1 or 2 days.

Note: Should these symptoms persist or worsen, patients should be instructed to see a physician.

Adverse Reactions: Subvirion, or split-virion vaccines contain purified portions of the virus rather than the entire virus. Generally, these have been shown to be associated with fewer adverse effects in children and young adults, while maintaining an immunogenicity similar to that of whole virus preparations. Because of their lower rates of side-effects, only split virus preparations are recommended for children under 13 years of age.

1. Local and systemic reactions are reported after vaccination with a split-virion influenza vaccine.

The data in Table I and Table II have been derived from three studies with three lots of IAF BioVac Inc. split-virion vaccine (A, B, C) compared to another subvirion vaccine (D) and to a whole virion vaccine (E) from IAF BioVac Inc.

There were very few reports of fever as defined by temperature over 38°C.

Soreness at the injection site was the most frequently reported symptom, and was generally rated as mild and resolved the day after vaccination.

For systemic symptoms, headache and muscle aches were the most common. As with local symptoms, these were generally reported as mild and of limited duration.

2. Immediate, allergic-type, responses, such as hives, angioedema, allergic asthma, or systemic anaphylaxis occur extremely rarely. These reactions probably result from sensitivity to some vaccine component - most likely residual egg proteins (see Contraindications).

There have been reports of other neurological illnesses, including facial paralysis, encephalitis, encephalopathy, demyelinating disease and labyrinthitis, associated with other influenza vaccines. Any relationship, other than temporal, to the vaccine has not been established.

Notification of Reactions: It is desirable that all unusual reactions, arising from any vaccination whatsoever, or following shortly thereafter, be reported to the manufacturer of the product and to the provincial epidemiologist.

Dosage And Administration: See Table III.

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

Administration: Caution: A separate sterile syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of hepatitis B virus, HIV virus, or other infectious agents from one person to another.

Check carefully the expiry date of the vaccine and note that this date applies to unopened containers only. Any vaccine beyond its expiry date should not be used.

Shake the container vigorously each time before withdrawing vaccine.

Never remove the rubber stopper from the container. Moisten the surface of the rubber stopper with a tampon of sterile cotton wool soaked in a suitable antiseptic and allow the antiseptic to act for a few moments, then wipe dry with a sterile dry swab. Draw into the syringe a volume of air equal to the amount of vaccine to be withdrawn from the container. Shake the container vigorously then pierce the center of the rubber stopper with the sterile needle attached to the syringe. Turn the vial upside down and inject into it the air from the syringe. Keeping the point of the needle immersed in the vaccine, withdraw immediately (into the syringe) the desired volume.

Disinfect the skin at the site of injection with a suitable antiseptic and wipe dry with a tampon of sterile cotton wool. The injection of 0.5 mL of Fluviral, should be given i.m., usually in the deltoid muscle.

Do not inject i.v.

To avoid injection into a vein, it is necessary, before injecting the dose of vaccine, to withdraw the piston of the syringe sufficiently to ensure that the needle has not entered a blood vessel.

All vaccines should be observed for about 15 minutes after vaccination. If an anaphylactic reaction develops, sterile epinephrine (1:1 000) should be administered.

It is desirable that the entire contents of a multidose vial be used at the same vaccination session.

Elimination: Fluviral S/F vaccine and materials used during vaccination may be disposed of in the same way as other drugs. Since Fluviral S/F is an inactivated vaccine, it presents no risk of contaminating the work area during manipulation.

Availability And Storage: Each dose of 0.5 mL contains: haemaglutinin 15 µg of each of the following strains: A/Texas/36/91 (H1N1), A/Johannesburg/33/94 (H3N2), B/Harbin/7/94. The composition of Fluviral S/F for the 1995-96 season has been established in agreement with the recommendations of the Canadian National Advisory Committee on Immunization (N.A.C.I.). Thimerosal 0.01% is present in both whole and split-virion preparations as a preservative. Split-virion vaccine also contains 0.025% gelatin as a stabilizer and trace residual amounts of deoxycholate. Vials of 5 mL (10 doses).

Store in the refrigerator between 2 and 8°C. Do not freeze. Freezing destroys activity. Do not use vaccine which has been frozen.

Reviewed Reviewed 1996