The viruses change in it from year to year, but not the
rest.
Mosby’s GenRx®, 10th ed.
Copyright © 2000 Mosby, Inc.
Influenza Virus Vaccine (001533)
Indications: Immunization, influenza
Pregnancy Category C
WHO Formulary
FDA Pre 1938 Drugs
FDA DRUG CLASS: Vaccines/Antisera
BRAND NAMES: Agrippal (Italy, South-Africa); Alorbat
(Germany); Begrivac (Austria, Germany); Begrivac F (Israel); Flu Shield (US);
Fluarix (New-Zealand, Mexico, Hong-Kong); Fluimmune (US); Fluogen (US);
Flushield (US); Fluvax (Australia, New-Zealand, Korea); Fluvirin (US);
Fluvirine (France); Fluzone (US); Hiberix (Australia); Inflexal (Spain,
Austria, Italy); Inflexal Berna (Philippines, South-Africa); Inflexal Berna Polyvalent
Vaccine (Malaysia); Influvac (Benin, Burkina-Faso, Ethiopia, Gambia, Ghana,
Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius,
Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, Sudan, Tanzania,
Tunia, Uganda, Zambia, Zimbabwe; Bahrain, Cyprus, Egypt, Iran, Iraq, Israel,
Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia,
Syria, United-Arab-Emirates);
Mutagrip (Germany, Belgium, Spain, Netherlands, France);
Sandovac (Austria); Vaxigrip (New-Zealand, Denmark, Netherlands, France,
Greece, Belgium, Bulgaria, Norway, Austria, Hong-Kong, Korea, Philippines, South-Africa,
Israel); X-Flu (South-Africa);
(International brand names outside U.S. in italics)
Influenza Virus Vaccine, Trivalent, Types A and B
(chromatograph- and filter-purified subvirion antigen)
1993-94 formula
DO NOT INJECT INTRAVENOUSLY Influenza virus vaccine,
trivalent, types A and B (purified subvirion) is a sterile injectable for
administration intramuscularly.
Influenza virus vaccine, trivalent, types A and B
(purified subvirion) is prepared from the allantoic fluids of chick embryos
inoculated with a specific type of influenza virus. During processing, not more
than 5 mcg of gentamicin sulfate per ml is added. The harvested virus is
inactivated with formaldehyde and is concentrated and purified.
Influenza virus vaccine, trivalent, types A and B
(purified subvirion) is concentrated and refined by a column-chromatographic
procedure. At the same time, addition of tri(n)butylphosphate and polysorbate
80, to the column-eluting fluids effects disruption and inactivation of a
significant proportion of the virus to smaller subunit particles. The recovered
subvirion (split-virus) suspension is freed of substantial portions of the disrupting
agents by dialysis and of other undesirable materials by selective filtration
through membranes of controlled pore size.
The viral antigen content has been standardized by
immunodiffusion tests, according to current U.S. Public Health Service
requirements. Each dose (0.5 ml) contains the proportions and not less than the
microgram amounts of hemagglutinin antigens (mcg HA) representative of the
specific components recommended for the current influenza season.
The vaccine contains 1:10,000 thimerosal (mercury
derivative) as a preservative. Gentamicin sulfate is used during manufacturing
but is not detectable in the final product by current assay procedures.
The administration of inactivated influenza vaccine to
high-risk persons
each year before the influenza season is the single most
important
influenza-control measure.1
The injection of antigens prepared from inactivated
influenza virus stimulates the production of specific antibodies. Protection is
afforded only against those strains of virus from which the vaccine is prepared
or closely related strains. With the passing of time, there may be major antigenic
changes in the prevalent strains, or there may be continuous and progressive
antigenic variation within a given virus subtype over time (antigenic drift),
so that infection or immunization with one strain may not induce immunity to
distantly related strains. Field studies of influenza vaccines conducted on
many occasions since the 1940’s have shown marked variation in efficacy, as
measured by protection from disease, ranging from undemonstrable to 70-80%. The
PHS regularly reviews the antigenic characteristics of current strains in order
to select those to be included in the contemporary vaccine.
Influenza virus vaccine is recommended for 1) high-risk
persons 6 months of age or older and for their medical-care providers or
household contacts; 2) for children and teenagers receiving long-term aspirin
therapy who, therefore, may be at increased risk of developing Reye’s syndrome
after an influenza virus infection; and 3) for other persons who wish to reduce
their chances of acquiring influenza.
Guidelines for the use of vaccine among different groups
are given below.
Groups at Increased Risk for Influenza-Related
Complications:
1. Otherwise healthy
persons 65 years of age or older.
2. Residents of
nursing homes and other chronic-care facilities housing patients of any age
with chronic medical conditions.
3. Adults and children
with chronic disorders of the pulmonary or cardiovascular systems requiring
regular medical follow-up or hospitalization during the preceding year,
including children with asthma.
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).
5. Children and
teenagers (aged 6 months to 18 years) who are receiving long-term aspirin
therapy and, therefore, may be at risk of developing Reye’s syndrome after
influenza infection.
Elderly persons and persons with certain chronic diseases
may develop lower post-vaccination antibody titers than healthy young adults
and thus may remain susceptible to influenza upper-respiratory-tract
infections. Nevertheless, even if such
persons develop influenza illness, the vaccine has been shown to be effective in
preventing lower-respiratory-tract involvement or other complications, thereby
reducing the risk of hospitalization and death.
Groups Potentially Capable of Nosocomial Transmission of
Influenza To
High-Risk Persons
Individuals attending high-risk persons can transmit
influenza infections to them while they are themselves incubating infection,
undergoing subclinical infection, or working despite the existence of symptoms.
Some high-risk persons, (e.g., the elderly, transplant recipients, persons with
acquired immunodeficiency syndrome (AIDS)), can have relatively low antibody
responses to influenza vaccine. Efforts to protect them against influenza may
be improved by reducing the chances that their care providers may expose them
to influenza. Therefore, the following groups should be vaccinated:
1. Physicians, nurses,
and other personnel in both hospital and outpatient settings.
2. Providers of home
care to high-risk persons (e.g., visiting nurses, volunteer workers) as well as
all household members of high-risk persons, including children, whether or not
they provide care.
General Population: Physicians should administer influenza
vaccine to any person who wishes to reduce his/her chances of acquiring
influenza infection. Persons who provide essential community services and
students or other healthy individuals in institutional settings (i.e., schools
and colleges) should be encouraged to receive vaccine to minimize the disruption
of routine activity during outbreaks.
Pregnant Women: Influenza-associated excess mortality
among pregnant women has not been documented, except in the largest pandemics
of 1918-19 and 1957-58. However, pregnant women who have medical conditions
increasing their risks of complications from influenza should be vaccinated, as
the vaccine is considered safe for pregnant women. Administering the vaccine after
the first trimester is a reasonable precaution to minimize any concern over the
theoretical possibility of teratogenicity. However, it is undesirable to delay
vaccination of pregnant women with high-risk conditions who will still be in
the first trimester of pregnancy when the influenza season begins.
Persons Infected With Human Immunodeficiency Virus (HIV):
Little information exists regarding the frequency and severity of influenza illness
in human immunodeficiency virus (HIV)-infected persons, but recent reports
suggest that symptoms may be prolonged and the risk of complications increased
for this high-risk group. Because influenza may result in serious illness and
complications, vaccination is a prudent precaution and will result in
protective antibody levels in many recipients. However, the antibody response
to vaccine may be low in persons with advanced HIV-related illnesses; a booster
dose of vaccine has not improved the immune response for these individuals.
Foreign Travelers: The risk of exposure to influenza during
foreign travel
varies, depending on, among other factors, season of travel
and
destination. Influenza can occur throughout the year in the
tropics; the
season of greatest influenza activity in the Southern
Hemisphere is
April-September. Because of the short incubation period for
influenza,
exposure to the virus during travel will often result in
clinical illness
that begins during travel, an inconvenience or potential
danger, especially
for persons at increased risk for complications. Persons
preparing to
travel to the tropics at any time of year or to the Southern
Hemisphere
during April-September should review their vaccination
histories. If not
vaccinated the previous fall/winter, they should be
considered for
influenza vaccination prior to travel. Persons in the
high-risk categories
especially should be encouraged to receive the vaccine. The
most current
available vaccine should be used. High-risk persons given
the previous
season’s vaccine prior to travel should be revaccinated in
the fall/winter
with current vaccine.1
If this product is to be used in an immunization program
sponsored by an
organization WHERE A TRADITIONAL PHYSICIAN/PATIENT
RELATIONSHIP DOES NOT
EXIST, each participant (or legal guardian) should be made
aware of the possible risks that have been associated with the use of influenza
virus vaccines, including the possible risk of a form of paralysis sometimes known
as Guillain-Barre syndrome. Information about possible side effects and adverse
reactions is presented below, and consent, preferably written, should be
obtained from the intended recipient (or legal guardian) before vaccine
administration.
Simultaneous Administration of Pneumoccal or Pediatric
Vaccines:
Pneumococcal vaccine and influenza vaccine can be given at
the same time at
different sites without increased side effects. However, it
should be
emphasized that whereas influenza vaccine is given annually,
it is
currently recommended that, with few exceptions,
pneumococcal vaccine be
given only once.1
It may be desirable to simultaneously administer influenza
vaccine, if indicated, with routine pediatric vaccine but at different sites.
Although studies have not been done, no diminution of immunogenicity or
enhancement of adverse reactions should be expected.1 Influenza vaccine should
not be given within 3 days of vaccination with pertussis vaccine.
INFLUENZA VIRUS VACCINE SHOULD NOT BE ADMINISTERED TO
INDIVIDUALS WITH A
HISTORY OF HYPERSENSITIVITY (ALLERGY) TO CHICKEN EGG OR
OTHER COMPONENTS OF
INFLUENZA VIRUS VACCINES WITHOUT FIRST CONSULTING A
PHYSICIAN (SEE ADVERSE
REACTIONS). Before being vaccinated, persons known to be
hypersensitive to
egg protein should be given a skin test or other
allergy-evaluating test,
using the Influenza Virus Vaccine as the antigen. Persons
with adverse
reactions to such testing should not be vaccinated.
Chemoprophylaxis may be
indicated for prevention of influenza A in such persons.
However, persons
with a history of anaphylactic hypersensitivity to vaccine
components but
who are also at highest risk for complications of influenza
infections may
benefit from vaccine after appropriate evaluation and
desensitization.1
Although gentamicin sulfate is not detectable in the final
product by current assay procedures, the vaccine should not be administered to
persons with known sensitivity to gentamicin or other aminoglycosides.
Persons with a past history of Guillain-Barre syndrome
(GBS) should not be given influenza virus vaccine.
Persons with acute febrile illnesses usually should not be
vaccinated until
their symptoms have abated. However, minor illness with or
without fever
should not contraindicate the use of influenza vaccine,
particularly in
children with a mild upper-respiratory-tract infection or
allergic
rhinitis.3
Patients with impaired immune responsiveness, whether due
to the use of immunosuppressive therapy (including irradiation, large amounts
of corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a
genetic defect, human immunodeficiency virus (HIV) infection, leukemia, lymphoma,
generalized malignancy, or other causes, may have a reduced antibody response
to active immunization procedures.1 Short-term (less than 2 weeks)
corticosteroid therapy or intra-articular, bursal, or tendon injections with
corticosteroids should not be immunosuppressive. Inactivated vaccines are not a risk to immunocompromised
individuals, although their efficacy may be substantially reduced. Because
patients with immunodeficiencies may not have an adequate response to
immunizing agents, they may remain susceptible despite having received an
appropriate vaccine.
If feasible, specific serum antibody titers or other
immunologic responses
may be determined after immunization to assess immunity.3
Chemoprophylaxis
may be indicated for high-risk persons who are expected to
have a poor
antibody response to influenza vaccine.1
Influenza virus is remarkably capricious antigenically,
and significant changes may occur from time to time. It is known definitely
that influenza vaccine, as now constituted, is not effective against all
possible strains of influenza virus. Protection is afforded most people only
against those strains of virus from which the vaccine is prepared or against
closely related strains .
Influenza vaccine often contains one or more antigens used
in previous years. However, immunity declines during the year following
immunization. Therefore, revaccination
on a yearly basis is necessary to provide optimal protection for the current
season. REMAINING VACCINE FROM THE PREVIOUS YEAR SHOULD NOT BE USED.
Epinephrine injection (1:1000) must be immediately
available should an acute anaphylactoid reaction occur due to any component of
the vaccine.
A separate sterile syringe and needle should be used for
each patient to prevent transmission of hepatitis B virus or other infectious
agents from one person to another. Reusable glass syringes and needles should
be heat-sterilized.
Animal reproduction studies have not been conducted with
influenza virus vaccine. It is also 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. (See INDICATIONS AND USAGE).
There have been conflicting reports4-13 on the effects of
influenza virus vaccine on the elimination of some drugs metabolized by the
hepatic cytochrome P-450 system. Hypoprothrombinemia in patients receiving
warfarin and elevated theophylline serum concentrations have occurred. Most
studies have failed to show any adverse effects of influenza vaccine in
patients receiving these drugs. Nevertheless, observation for possible enhanced
drug effect or toxicity is indicated for those persons taking theophylline preparations
or warfarin sodium.
Individuals receiving therapy with immunosuppressive
agents (large amounts of corticosteroids, antimetabolites, alkylating agents,
cytotoxic agents) may not respond optimally to active immunization procedures.
(See WARNINGS.)
Side effects of influenza vaccine are generally
inconsequential in adults and occur at low frequency, but at younger ages side
effects may be more common.
BECAUSE INFLUENZA VACCINE CONTAINS ONLY NONINFECTIOUS
VIRUSES, IT CANNOT
CAUSE INFLUENZA. Occasional cases of respiratory disease
following vaccination represent coincidental illnesses unrelated to influenza vaccination.
The most frequent side effect of vaccination is soreness
around the vaccination site for up to 2 days; this occurs in less than one-third
of vaccinees.
In addition, the following three types of systemic
reactions have occurred:
1. Fever, malaise,
myalgia, and other systemic symptoms occur infrequently and most often affect
persons who have had no exposure to the influenza virus antigens in the vaccine
(e.g., young children). These reactions
begin 6 to 12 hours after vaccination and can persist for 1 or 2 days.
2. Immediate,
presumably allergic, reactions such as hives; angioedema, allergic asthma, or systemic
anaphylaxis occur extremely rarely after influenza vaccination. These reactions
probably result from hypersensitivity to some vaccine component - the majority
are most likely residual egg protein. Although current influenza vaccines contain
only a small quantity of egg protein, this protein may induce immediate
hypersensitivity reactions in persons with severe egg allergy. Persons who have
developed those who have developed hives, have had swelling of the lips or tongue,
or experienced acute respiratory distress or collapse after eating eggs should
consult a physician for appropriate evaluation to assist in determining whether
vaccination may proceed or should be deferred. Persons with a documented
immunoglobulin E (IgE)-mediated hypersensitivity to eggs, including those who
have experienced occupational asthma or other allergic responses from
occupational exposure to egg protein, may also be at increased risk for
reactions from influenza vaccine, and similar consultation should be
considered. The protocol for influenza vaccination developed by Murphy and
Strunk may be considered for patients who have egg allergies and medical
conditions that place them at increased risk for influenza infection or its
complications.15 The potential exists for hypersensitivity reactions to any
vaccine component. Although exposure to vaccines containing thimerosal can lead
to induction of hypersensitivity, most patients do not develop reactions to
thimerosal administered as a component of vaccines even when patch or
intradermal tests for thimerosal indicate hypersensitivity. When it has been
reported, hypersensitivity to thimerosal has usually consisted of local delayed
type hypersensitivity reactions.1
3. Guillain-Barre
syndrome (GBS). This is an uncommon illness characterized by ascending
paralysis which is usually self-limited and reversible. Though most persons
with GBS recover without residual weakness, approximately 5% of cases are
fatal. Before 1976, no association of GBS with influenza vaccine use was
recognized.
Except for the 1976-77 swine influenza vaccine, subsequent
vaccines prepared from other virus strains have not been clearly associated
with an increased frequency of Guillain-Barre syndrome.1, 16-19 Although, in 1990-91,
there may have been a small increase in GBS cases in vaccinated persons 18 to
64 years of age, the epidemiologic features of the possible association of the
1990-91 vaccine with GBS were not as convincing as those found with the swine
influenza vaccine. It is difficult to make a precise estimate of risk for a
rare condition such as GBS.1 Therefore, candidates for influenza virus vaccine
should be made aware of the possible risks, including GBS, and the benefits of
administration.
Other neurologic disorders, including encephalopathies,
not defined as GBS,
have been temporarily associated with influenza vaccination.20
Although influenza virus vaccine often contains one or
more antigens used in previous years, immunity declines during the year
following vaccination.
Therefore, a history of vaccination in any previous year
with a vaccine
containing one or more antigens included in the current
vaccine does NOT
preclude the need for revaccination for the 1993-1994
influenza season to
provide optimal protection. REMAINING VACCINE FROM THE
PREVIOUS YEAR SHOULD
Influenza vaccine may be offered to high-risk persons
presenting for routine care or hospitalization beginning in September, but not
until new vaccine is available (see INDICATIONS AND USAGE, Vaccination of Other
Groups for foreign travel, related exceptions). Opportunities to vaccinate persons
at high risk for complications of influenza should not be missed. In the United States, influenza activity
generally peaks between late December and early March, and high levels of
influenza activity infrequently occur in the contiguous 48 states before
December. Therefore, the optimal time for organized vaccination campaigns for
high-risk persons usually is the period between mid-October and mid-November.
In facilities such as nursing homes it is particularly important to avoid
administering vaccine too far in advance of the influenza season because
antibody may begin to decline within a few months. Such vaccination programs
may be undertaken as soon as current vaccine is available in September or
October if regional influenza activity is expected to begin earlier than
normal.
Children less than 9 years of age who have not been
vaccinated previously should receive two doses with at least 1 month between
doses to maximize the chance of a satisfactory antibody response to all three
vaccine antigens. The second dose should be given before December if possible. Vaccine should continue to be offered to
both children and adults up to and even after influenza virus activity is
documented in a community which may be as late as April in some years.
Parenteral drug products should be inspected visually for
particulate matter and discoloration, whenever solution and container permit.
DO NOT INJECT INTRAVENOUSLY. Injections of FluShield are
recommended to be given intramuscularly. The recommended site is the deltoid
muscle for adults and older children. The preferred site for infants and young children
is the anterolateral aspect of the thigh musculature. Because of lack of
adequate evaluation of other route in high-risk persons, the preferred route of
vaccination is intramuscularly whenever possible. Before injection, 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. SeeTABLE 1 for pediatric dosages.
AGE GROUP DOSAGE
SCHEDULE
9 years and
older 0.5
ml (one dose)
3 to 8
years 0.5
ml (1 or 2 doses)*
6 to 35
months 0.25
ml (1 or 2 doses)*
For those under 13 years, only split-virus (subvirion)
vaccine is recommended.
·
A single dose is considered sufficient for those under
9 years who have received at least 1 dose of influenza virus vaccine. With the
2-dose regimen, allow 4 weeks or more between doses. Both doses are recommended
for maximum protection.
Immunogenicity and reactogenicity of split- and
whole-virus vaccines are
similar in adults when used according to the recommended
dosage.1
Storage: Store between 2°-8°C (35°-46° F). Potency is
destroyed by freezing; do not use Influenza Virus Vaccine that has been frozen.
1. Recommendations of
the Advisory Committee on Immunization Practices—
Prevention and Control of Influenza: Part 1, vaccines.
MMWR 1993: 42 (no.
2. ACIP. Pneumococcal
polysaccharride vaccine. MMWR 1989: 38: 64- 8, 73-6.
3. American Academy of
Pediatrics: Report of the Committee on Infectious Diseases, 22nd ed.
Elk Grove Village, IL, American Academy of Pediatrics, 1991.
4. KRAMER, P. and
McCLAIN, C.: Depression of aminopyrine metabolism by influenza vaccination.
NEJM 305: 1262, 1981.
5. RENTON, K. et al:
Decreased elimination of theophylline after influenza vaccination. Canadian
Med. Assoc. J. 123: 288, 1980.
6. GOLDSTEIN, R. S. et
al: Decreased elimination of theophylline after influenza vaccination. Canadian
Med. Assoc. J. 126: 470, 1982.
7. BRITTON, L. and
RUBEN, F. L.: Serum and theophylline levels after influenza vaccination.
Canadian Med. Assoc. J. 126: 1375, 1982.
8. FISCHER, R. G. et
al: Influence of trivalent influenza vaccine on serum theophylline levels.
Canadian Med. Assoc. J. 126: 1312-1313, 1982.
9. SAN JOAQUIN, V. H.,
REYES, S., and MARKS, M. I.: Influenza vaccination in asthmatic children on
maintenance theophylline therapy. Clin. Pediatrics 21: 724-726, 1982.
10. STULTS, B. and
HASISAKI, P.: Influenza vaccination and theophylline pharmacokinetics in
patients with chronic obstructive lung disease. West J. Med. 139: 651-654, 1983.
11. PATRIARCA, P.A. et
al: Influenza vaccination and warfarin or theophylline toxicity in nursing-home
residents. New Eng. J. Med.308: 1601, 1983.
12. MEREDITH, C. G. et
al: Effects of influenza virus vaccine on hepatic drug metabolism. Clin. Pharm.
Ther. 37: 396-401, 1985.
13. LIPSKY, B. A. et al:
Influenza vaccination and warfarin anticoagulation. Ann. Int. Med. 100:
835-837, 1984.
14. KRAMER, P. et al:
Effect of Influenza vaccine on warfarin anticoagulation. Clin. Pharmacol. Ther.
35: 416, 1984.
15. MURPHY, K. R. and
STRUNK, R. L.: Safe administration of Influenza vaccine in asthmatic children
hypersensitive to egg proteins. J. Pediatr.106:
931-3, 1985.
16. SCHONBERGER, L. et
al: Guillain-Barre syndrome following vaccination in the National Influenza
Immunization Program, United States 1976-1977. Am. J. Epidemiol. 110: 105, 1979.
17. SCHONBERGER, L. et
al: Guillain-Barre syndrome: Its epidemiology and associations with influenza
vaccination. Ann. Neurol. 9 (Supplement: 31, 1981).
18. HURWITZ, E. et al:
Guillain-Barre syndrome and the 1978-1979 influenza vaccine. New Eng. J. Med.
304: 1557, 1981.
19. KAPLAN, J. et al:
Guillain-Barre syndrome in the United States, 1979-1980 and 1980-1981. Lack of
association with influenza vaccination.
20. RETAILLIAU, H. et al:
Illness after influenza vaccination reported through a nation-wide surveillance
system, 1976-1977. Am. J. Epidemiol.111:
170, 1980.
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INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.