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Varicella Virus Vaccine Live (Systemic)


VA CLASSIFICATION
Primary: IM100

Commonly used brand name(s): Varivax.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Immunizing agent (active)—

Indications

General considerations
Varicella-zoster virus (VZV) is the cause of two diseases, varicella (chickenpox), which is a primary infection, and zoster (shingles), a secondary infection caused by reactivation of latent VZV {02} {03}. VZV is transmitted person-to-person through direct contact with skin lesions and by airborne respiratory droplets {02} {03}. Skin vesicles in varicella and zoster contain high titers of infectious virus, and patients with zoster can transmit varicella to susceptible contacts {03}. Varicella is one of the most contagious diseases, resembling pertussis and measles {03}. Within households, 80 to 90% of exposed susceptible contacts will develop varicella {03}.

A reliable history of varicella is considered a valid measure of immunity {02} {11}. Because the rash is distinctive and subclinical cases rarely occur, most parents know if their child has had varicella {02}. A negative history of varicella substantiated by a parent may be more accurate than a self-reported negative history given by an adult {02}.

Serologic tests have been used to assess the accuracy of reported histories of varicella {02}. In adults, a positive history of chickenpox is highly predictive of serologic immunity to varicella virus (97 to 99% of persons are seropositive); however, the majority (71 to 93%) of adults who have negative or uncertain history are also seropositive {02}.

Infants, children, adolescents, and adults should be assessed for varicella immune status, and those who are susceptible should be vaccinated {02} {11}. Although usually a benign illness, varicella may have severe complications among both children and adults {11}. These include pneumonia, viral dissemination leading to encephalitis and/or multiple organ involvement, secondary bacterial infections, and hemorrhagic complications {11}. Total burden of disease is greater in children; however, varicella causes a higher risk of hospitalizations and death in adults than in children {11}.

All susceptible health care workers should ensure that they are immune to varicella {02}. In health care institutions, serologic screening of personnel who have a negative or uncertain history of varicella is likely to be cost-effective {02}. However, routine testing for varicella immunity after two doses of vaccine is not necessary for the management of vaccinated health care workers who may be exposed to varicella, because 99% of persons are seropositive after the second dose {02}.

Vaccination should be considered for unvaccinated health care workers who are exposed to varicella and whose immunity is not documented {02}. However, since the protective effects of postexposure vaccination are unknown, persons vaccinated after an exposure should be managed in the manner recommended for unvaccinated persons {02}.

Accepted

Varicella virus (prophylaxis)—Varicella virus vaccine live is indicated for immunization against VZV infection {01} {02} {03} {04} {06}. The American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommend that all individuals 12 months of age and older be immunized against varicella {01} {02} {03} {04} {06}, including:    • Children 12 to 18 months of age {02} {04} {06}. All children should be routinely vaccinated at 12 to 18 months of age {02}. Varicella virus vaccine live may be administered to all children at this age, regardless of whether or not they have a history of varicella {02}. However, vaccination is not necessary for children who have reliable histories of varicella {02}.
   • Children 19 months to 13 years of age {02} {04} {06}. Varicella virus vaccine live is recommended for all susceptible children by their 13th birthday {02}. After 12 years of age natural varicella is more severe and complications are more frequent {02}. ACIP recommended establishing a routine immunization visit at 11 to 12 years of age to review immunization status and to administer necessary vaccinations {02}. Varicella virus vaccine live should be administered to all susceptible children during this routine visit {02}.
   • Adolescents 13 years of age and older and adults {02} {04} {08}. Natural varicella infection is more severe and complications are more frequent in adolescents 13 years of age and older and adults; therefore, varicella immunity is desirable in these age groups {02}. Adolescents 13 years of age and older and adults who have reliable histories of varicella are considered immune {02} {08}. Those who do not have such histories are considered susceptible and can be tested to determine immune status or can be vaccinated without testing {02}. However, since 71 to 93% of adults who do not have a reliable history of varicella are actually immune, serologic testing before vaccination is likely to be cost-effective for both adolescents and adults {02}. Vaccination should be considered for the following groups of adolescents 13 years of age and older and adults {02}:    —Persons who have close contact with individuals at high risk for serious complications (e.g., health care workers and family contacts of immunocompromised persons) {02}.
   —Persons who live or work in environments in which transmission of VZV is likely (e.g., teachers of young children, day-care employees, and residents and staff in institutional settings) {02}.
   —Persons who live or work in environments in which varicella transmission can occur (e.g., college students, inmates and staff of correctional institutions, and military personnel) {02}.
   —Nonpregnant women of childbearing age {02}. Vaccination of women who are not pregnant, but who may become pregnant in the future, will reduce the risk for VZV transmission to the fetus {02}. Varicella immunity may be ascertained at any routine health care visit or in any setting in which vaccination history may be reviewed (e.g., upon college entry) {02}. Women should be asked if they are pregnant and advised to avoid pregnancy for 1 month following each dose of vaccine {02}.
   —International travelers {02}. Vaccination should be considered for international travelers who do not have evidence of immunity to VZV (e.g., serologic tests), especially if the traveler expects to have close personal contact with local populations, because varicella is endemic in most countries {02}. However, all susceptible adolescents and adults should be vaccinated prior to international travel {11}.




Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Varicella virus vaccine live is a preparation of the Oka/Merck strain of live, attenuated varicella virus {01} {02} {03} {04}. The virus was initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures, and propagated in human diploid cell cultures (WI-38) {01} {09}. The virus for varicella vaccine undergoes further passage in human diploid cell cultures (MRC 5) that are free of adventitious agents {01} {09}. The live attenuated vaccine is a lyophilized preparation {01} {03}.

Mechanism of action/Effect:

Vaccination with varicella virus vaccine live induces varicella antibodies and a cell-mediated immune response {11}, which produce active immunity against varicella infection {01} {04}.


Protective effect

In a double-blind, placebo-controlled trial of children 1 to 14 years of age, using a high-titer experimental vaccine, the efficacy was 100% in the first year after vaccination {04}. According to other unpublished studies from the manufacturer, the protection against any disease in vaccinees after household exposure was approximately 70%, and greater than 95% against more severe disease {01} {04}. Rates of protection are similar in adults {04}. All studies demonstrate high rates of protection against severe disease {04}.

Varicella in vaccinees has been much milder than that occurring in unvaccinated children, with fewer skin lesions (range 15 to 32), lower rates of fever (10% of patients with a temperature ³ 39 °C [102 °F]), and rapid recovery {04}. At times, the disease is so mild that it is not easily recognizable as varicella because the skin lesions may resemble insect bites {04}. Nevertheless, vaccine recipients with mild disease may be potentially infectious to susceptible persons {04}.


Duration of protective effect

Waning immunity in vaccine recipients has not been demonstrated, at least in the context of continued varicella-zoster virus (VZV) circulation {04}. The rate of varicella after immunization during 7 years of study has averaged from less than 1 to 4.4% per year after exposure to wild virus {04}. The rate has not increased with time after immunization {04}.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans {01}. However, the effects of varicella virus vaccine live on the fetus are unknown; therefore, pregnant women should not be vaccinated {01} {02} {03} {04}. When postpubertal women are immunized, pregnancy should be avoided for 30 days after immunization {02} {03} {04}. For susceptible persons, having a pregnant household member is not a contraindication to vaccination {02} {03} {04}.

It is recommended that pregnancy be avoided for 3 months following immunization with the varicella virus vaccine live {01}.

If a pregnant woman is vaccinated or becomes pregnant within 30 days of vaccination, she should be counseled about potential effects on the fetus {02}. Wild-type varicella poses only a very small risk to the fetus {02}. Since the virulence of the attenuated virus used in the vaccine is less than that of the wild-type virus, the risk to the fetus, if any, should be even lower {02}. In most circumstances, the decision to terminate a pregnancy should not be based on whether vaccine was administered during pregnancy {02}.

The manufacturer of varicella virus vaccine live, in collaboration with the Centers for Disease Control and Prevention (CDC), has established the VARIVAX Pregnancy Registry to monitor the maternal-fetal outcomes of pregnant women who are inadvertently administered varicella virus vaccine live 3 months before or at any time during pregnancy (telephone: 1-800-986-8999) {02} {04}. An annual report will be sent to health care providers participating in the registry {05}.

Studies have not been done in animals {01}.

FDA Pregnancy Category C {01}.

Breast-feeding

It is not known whether varicella vaccine virus is distributed into breast milk or if it is infectious to infants {01} {02} {03} {04} {06}. However, varicella virus vaccine live may be considered for a susceptible breast-feeding mother if the risk of exposure to natural VZV is high {02} {03} {04} {06}.

Pediatrics

No information is available about the reactivity, immunogenicity, or the efficacy of the varicella virus vaccine live in infants and children up to 12 months of age {01} {02} {03} {04} {06}. Use is not recommended {01} {02} {03} {04} {06}.

It is not known whether Reye's syndrome results from the administration of salicylates after vaccination for varicella in children {03} {04}. No cases have been reported {03} {04}. However, the manufacturer of the vaccine recommends that salicylates not be administered for 6 weeks after the varicella virus vaccine live has been given because an association between Reye's syndrome, natural varicella, and salicylates is well established {01} {03} {04}. Physicians should weigh the theoretical risks associated with varicella virus vaccine live against the known risks of the wild-type virus in children receiving long-term salicylate therapy {03} {04}.

The potential risks of vaccination with the attenuated virus must always be weighed against the potential risks of becoming infected with wild-type VZV infection in children receiving corticosteroids {03} {04}.

Varicella virus vaccine live should not be administered to children who are receiving high doses of systemic corticosteroids (2 mg per kg of body weight per day or more of prednisone or its equivalent, or 20 mg per day of prednisone if their weight is less than 10 kg) for more than 1 month {03} {04}. After corticosteroid use at this dosage has been discontinued for 3 months, a child may be immunized {03} {04}. However, most experts agree that with varicella virus vaccine live an interval of 1 month or more after discontinuation of corticosteroid use is probably sufficient to administer safely the vaccine {03} {04}.

Children with no history of varicella who are receiving systemic corticosteroids for conditions such as nephrosis and asthma may be immunized if not otherwise immunosuppressed, assuming that they are receiving less than 2 mg per kg of body weight per day of prednisone or its equivalent, or 20 mg per day of prednisone if their weight is less than 10 kg {03} {04}. Some experts, however, suggest discontinuing corticosteroid use for 2 to 3 weeks after immunization, if possible {03} {04}. In studies in Japan, children with nephrosis receiving these doses of systemic corticosteroids were immunized safely when corticosteroid therapy was suspended for 1 to 2 weeks before immunization {03} {04}. Most experts agree that immunization of children receiving only inhaled corticosteroids would not increase the risk of disease from varicella virus vaccine live, although no studies in such children have been performed {03} {04}.

Varicella virus vaccine live is not licensed for routine use in children with malignancies {03} {04}. However, immunization should be considered when a child with acute lymphocytic leukemia (ALL) has been in continuous remission for at least 1 year and has a lymphocyte count over 700/mcL and platelet count over 100,000/mcL 24 hours before vaccination {03} {04}. Immunization has been shown to be safe, immunogenic, and effective in these children {01} {03} {04} {10}.

Note: The vaccine may be obtained free for use in a research protocol {01} {03}. This protocol monitors and evaluates safety and requires approval by the appropriate institutional investigative board {03}. To immunize a child who has ALL, the following organization should be consulted: The Varivax Coordinating Center, Bio-Pharm Clinical Services, Inc., 4 Valley Square, Blue Bell, PA 19422; telephone: (215) 283-0897 {01} {03}.



Geriatrics


No information is available on the relationship of age to the effects of varicella virus vaccine live in geriatric patients {01}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Blood products or
Immune globulins    (whether immune globulin [IG] can interfere with varicella virus vaccine live–induced immunity is unknown, although IG can interfere with immunity induced by other live virus vaccines; as with other live virus vaccines, varicella virus vaccine live should not be administered within at least 5 months after receipt of any form of IG or other blood products; transplacental antibodies to VZV do not interfere with the immunogenicity of varicella virus vaccine live at 12 months of age or older {01} {03} {06} {12})


» Immunosuppressive agents or
» Radiation therapy    (because normal defense mechanisms are suppressed, concurrent use of the varicella virus vaccine live may potentiate the replication of the vaccine virus, may increase the side/adverse effects of the vaccine, and/or may decrease the patient's antibody response to varicella virus vaccine live; individuals who are taking immunosuppressive agents may develop a more extensive vaccine-associated rash or disseminated disease. The interval between discontinuation of the medications that cause immunosuppression and restoration of the patient's ability to respond to varicella virus vaccine live depends on the intensity and type of immunosuppressive medication used, the underlying disease, and other factors {01} {03} {06} {10})


Corticosteroids{11}    (short-term or alternate-day treatment with low to moderate dosage of corticosteroids is not a contraindication for receiving live virus vaccines; low-to-moderate dosage is considered to be prednisone [or its equivalent] 2 mg per kg of body weight per day; if the patient weighs more than 10 kg, a low-to-moderate dosage is considered to be less than 20 mg a day; patients receiving higher doses of corticosteroids should wait a period of 3 months after completion of corticosteroid therapy before receiving varicella virus vaccine live; topical or inhaled forms of corticosteroids are not considered immunosuppressive and no discontinuation of corticosteroid therapy is necessary before receiving varicella virus vaccine live {03} {10})


» Salicylates    (it is not known whether Reye's syndrome results from the administration of salicylates after vaccination for varicella in children; no cases have been reported; however, the manufacturer of the vaccine recommends that salicylates not be administered for 6 weeks after the varicella virus vaccine live has been given because an association between Reye's syndrome, natural varicella, and salicylates is well established; physicians should weigh the theoretical risks associated with varicella virus vaccine live against the known risks of the wild-type virus in children receiving long-term salicylate therapy {01} {03} {04})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Febrile illness    (the decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the cause of illness and the severity of symptoms; minor illnesses, such as upper respiratory infection, do not preclude administration of vaccine; for persons whose compliance with medical care cannot be assured, every opportunity should be taken to provide appropriate vaccinations {03})

    (children with moderate or severe febrile illnesses can be vaccinated as soon as they have recovered from the acute phase of the illness; this wait avoids superimposing adverse effects of vaccination on the underlying illness or mistakenly attributing a manifestation of the underlying illness to the vaccine; performing routine physical examinations and measuring temperatures are not prerequisites for vaccinating infants and children who appear to be in good health; asking the parent or guardian if the child is ill, postponing vaccination for children with moderate or severe febrile illnesses, and vaccinating those without contraindications are appropriate procedures in childhood immunization programs {03})


» Immunodeficiency conditions, congenital or hereditary, history of or
» Immunodeficiency conditions, primary or acquired    (varicella virus vaccine live should not be given routinely to immunocompromised individuals, such as those with congenital immunodeficiency, blood dyscrasias, leukemia, lymphoma, symptomatic human immunodeficiency virus [HIV] infection, and malignancy for which they are receiving immunosuppressive therapy; the exceptions include children with acute lymphocytic leukemia [ALL] under study conditions [see Pediatrics ] {03} {10})

    (asymptomatic HIV infection also is a contraindication for immunization, but since the risk in these persons is so far only theoretical, routine screening for HIV is not indicated; children with a family history of hereditary immunodeficiency and who exhibit immunodeficiency should be excluded from immunization; the presence of an immunodeficient or HIV-positive family member does not contraindicate vaccine use in other family members {01} {02} {03} {06} {10})


» Tuberculosis, active, untreated{01}
Risk-benefit should be considered when the following medical problems exist
Allergy to gelatin    (patients allergic to gelatin also may be allergic to varicella virus vaccine live, since gelatin is used as a stabilizer in the production of the vaccine {01} {03} {06})


Hypersensitivity to neomycin    (patients allergic to systemic or topical neomycin may be allergic to the varicella virus vaccine live because each 0.5-mL dose contains trace amounts of neomycin, which is used in the production of the vaccine to prevent bacterial overgrowth in the viral culture. A history of delayed-type allergic reaction [contact dermatitis] to neomycin generally does not preclude immunization. However, a history of anaphylaxis due to topically or systemically administered neomycin precludes immunization {01} {03} {06})


Thrombocytopenia or vaccine-associated thrombocytopenia    (persons who experienced thrombocytopenia with the first dose of vaccine may develop thrombocytopenia with additional doses. These persons should have serological testing performed in order to determine the need for additional doses of vaccine. The risk:benefit ratio should be evaluated before vaccination is considered in such cases {01})


Sensitivity to varicella virus vaccine live{01}{03}{06}


Side/Adverse Effects

Note: The spread of vaccine virus from healthy vaccinees to other persons is theoretically possible because varicella vaccine virus has been recovered from vaccine recipients with skin lesions {03}. The spread of vaccine virus to others from vaccinees with leukemia who had a vaccine-associated rash was observed in clinical trials conducted prior to vaccine licensure {03} {11}. Contact cases have been subclinical or have developed extremely mild illness, indicating that the vaccine virus remains attenuated when transmitted {03}. Since licensure, with more than 11 million doses of vaccine distributed, 3 cases of transmission from healthy vaccine recipients to household members have been documented {11}. Transmission has occurred only in the presence of rash in the vaccinee {11}.
A zoster-like illness, marked by rash and minimal or absent systemic symptoms, has been reported in 8 of 9000 healthy children who were immunized with varicella virus vaccine live {03}. No case was severe {03}. This incidence was no higher than that occurring after natural varicella {03}. Zoster is unusual in childhood, and is estimated to occur with a frequency of 77 cases per 100,000 person-years {03}. To date, the frequency in vaccinated children after 7 years of follow-up is 18 cases per 100,000 person-years {03}. Moreover, in children with leukemia, zoster is less common after vaccination than after natural varicella infection {03}. In the U.S., more than 1500 adults have been immunized in clinical trials, with 11 to 13 years of follow-up, and the only case of zoster was caused by the wild virus {03}. Post-marketing surveillance has documented herpes zoster due to the vaccine virus among both children and adults; however, reported rates are lower than seen following natural disease {11}.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Fever over 39 °C (102 °F){01}{02}

Incidence less frequent
    
Varicella-like skin rash{01}{02}{08}

Incidence rare
    
Anaphylactic reaction {01}{02}(difficulty in breathing or swallowing; hives; itching, especially of feet or hands; reddening of skin, especially around ears; swelling of eyes, face, or inside of nose; unusual tiredness or weakness, sudden and severe)
    
encephalitis {01}{02}(confusion; irritability; severe or continuing headache; stiff neck; vomiting)
    
lymphadenopathy {01}(swelling of glands in neck)
    
myalgia or arthralgia {01}(muscle or joint pain)
    
thrombocytopenia{01} (black, tarry stools; blood in urine or stools; pinpoint red spots on skin; unusual bleeding or bruising)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Fever of 37.7 °C (100 °F) or higher but below 39 °C (102 °F){01}{02}{08}
    
pain, redness, or soreness at injection site{01}{02}{03}{08}

Incidence less frequent
    
Gastrointestinal effects {01}(abdominal pain; diarrhea; nausea; vomiting)
    
respiratory illness {01}{03}{08}(common cold; congestion; cough; sore throat)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Varicella Virus Vaccine Live (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before receiving this vaccine
»   Conditions affecting use, especially:
Sensitivity to varicella virus vaccine live, allergy to gelatin, or hypersensitivity to neomycin

Pregnancy—Use of varicella virus vaccine live during pregnancy or becoming pregnant within 30 days of immunization is not recommended. It is recommended that pregnancy be avoided for 3 months following immunization with the varicella virus vaccine live





Breast-feeding—Varicella virus vaccine live may be used with caution in nursing mothers, especially those at high risk for exposure to varicella infection





Use in children—Use is not recommended for infants younger than 12 months of age

Other medications, especially immunosuppressive agents, radiation therapy, and salicylates
Other medical problems, especially febrile illness; immunodeficiency conditions, congenital or hereditary, history of, or immunodeficiency conditions, primary or acquired; or tuberculosis, active, untreated

Proper use of this vaccine

» Proper dosing

Precautions after receiving this vaccine
Do not become pregnant for 3 months after receiving varicella virus vaccine live without first checking with your doctor.

Tell your doctor that you have received this vaccine:    • If you are to receive blood transfusions or other blood products within 5 months of receiving this vaccine.
   • If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 2 months after receiving this vaccine.
   • If you are to receive any other live virus vaccines within 1 month of receiving this vaccine.


Do not take aspirin or aspirin products for 6 weeks after receiving this vaccine.


Side/adverse effects
Signs of potential side effects, especially fever over 39 °C (102 °F), varicella-like skin rash, anaphylactic reaction, encephalitis, lymphadenopathy, myalgia or arthralgia, and thrombocytopenia


General Dosing Information
Although systemic reactions to varicella virus vaccine live are rare, anaphylaxis among vaccine recipients has been reported {01} {02}. Therefore, appropriate precautions should be taken prior to varicella virus vaccine live injection to prevent allergic or other unwanted reactions {01} {02}. Precautions should include review of the patient's history regarding possible sensitivity and the ready availability of 1:1000 epinephrine injection and other appropriate agents used for control of immediate allergic reactions {01}.

Varicella virus vaccine live is administered subcutaneously {01}. It should not be injected intravenously {01} {03}.

When sterilizing syringes and skin before vaccination, care should be taken to avoid contact between vaccine and preservatives, antiseptics, detergents, and disinfectants, since the vaccine virus is easily inactivated by these substances {01}.

To prevent inactivation of the vaccine, it is recommended that only the diluent provided by the manufacturer be used for vaccine reconstitution {01}.

Whether administration of immune globulin (IG) can interfere with the immunological response to varicella vaccination is not known {03} {04}. However, IG administration can interfere with the response to other live virus vaccines, such as measles vaccine, and because of the potential inhibition of the response to varicella vaccination by passively transferred antibodies, varicella virus vaccine live should not be given for at least 5 months after the administration of IG preparations, including varicella zoster immune globulin (VZIG), blood products (except washed red blood cells), or plasma transfusion {03} {04}. Infants and children receiving respiratory syncytial virus immune globulin intravenous (RSV-IGIV) should not receive varicella virus vaccine live until at least 9 months after the last dose of RSV-IGIV {04}.

If possible, IG preparations should not be administered for 3 weeks after vaccination {04}. If an IG preparation is given in the interval before vaccination, the recipient either should be revaccinated 5 months later or tested for varicella immunity 6 months later and revaccinated if seronegative {04}.

Healthy persons in whom varicella-like rash develops following vaccination appear to have a minimal risk for transmission of vaccine virus to their close contacts (e.g., family members) {02}. Seroconversion has been documented in healthy siblings of healthy vaccinees in whom rash did not develop, although such an occurrence is rare {02}. Vaccinees in whom vaccine-related rash develops, particularly health care workers and household contacts of immunocompromised persons, should avoid contact with susceptible persons who are at high risk for severe complications {02}. If a susceptible, immunocompromised person is inadvertently exposed to a person who has a vaccine-related rash, VZIG need not be administered because disease associated with this type of transmission is expected to be mild {02}.

Varicella virus vaccine live may be given simultaneously with measles, mumps, and rubella virus vaccine live, provided different syringes and injection sites are used {03}. If not given simultaneously, the interval between administration of varicella virus vaccine live and measles, mumps, and rubella virus vaccine live should be at least 1 month {01} {03}. Although further immunogenicity studies are needed on the use of varicella virus vaccine live administered simultaneously with diphtheria and tetanus toxoids, and pertussis vaccine adsorbed (DTP or DTaP), poliovirus vaccine live oral (OPV), inactivated poliovirus vaccine (IPV or eIPV), hepatitis B vaccine, and Haemophilus influenzae type b vaccine, no reason exists to suspect that varicella virus vaccine live will affect the immune response to these vaccines {03}. When necessary, varicella virus vaccine live may be given simultaneously or at any interval after or before these vaccines {03}.

For treatment of adverse effects
Recommended treatment includes:    • For mild hypersensitivity reaction—Administering antihistamines and, if necessary, corticosteroids {07}. In mild anaphylaxis, antihistamines or subcutaneous epinephrine may be all that is necessary if the condition is progressing slowly and is not life-threatening, regardless of the organ or system affected {07}. Under these circumstances, the risks associated with intravenous epinephrine administration outweigh the benefits {07}.
   • For severe hypersensitivity or anaphylactic reaction—Administering epinephrine {07}. Antihistamines or corticosteroids may also be administered as required {07}. Epinephrine is the treatment of choice for severe hypersensitivity or anaphylactic reaction {07}. If the patient's condition is not stable, epinephrine should be infused {07}. Norepinephrine may be preferable if there is no bronchospasm {07}. For bronchospasm, epinephrine should be given with corticosteroids {07}. Other bronchodilators, such as intravenous aminophylline or albuterol by nebulization, also should be considered {07}.



Parenteral Dosage Forms

VARICELLA VIRUS VACCINE LIVE FOR INJECTION

Usual adult and adolescent dose
Immunizing agent (active)
Subcutaneous, 0.5 mL, preferably into the outer aspect of the upper arm {01}:

First dose—At initial visit.

Second dose—Four to eight weeks after the first dose {01}.


Usual pediatric dose
Immunizing agent (active)
Infants up to 12 months of age—Use is not recommended {01} {03}.

Infants and children 12 months to 12 years of age—Subcutaneous, 0.5 mL as a single dose, preferably into the outer aspect of the upper arm {01}.


Strength(s) usually available
U.S.—


Not less than 1350 plaque forming units (PFU) of Oka/Merck varicella virus per 0.5 mL (Rx) [Varivax (may contain neomycin and gelatin)]{01}{09}

Canada—
Not commercially available.

Packaging and storage:
Store the vaccine below -15 °C (+5 °F) until the time of reconstitution {01}. The diluent should be stored below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F). The diluent may be stored at room temperature or in the refrigerator {01}.

Preparation of dosage form:
To reconstitute, only the diluent provided by the manufacturer should be used since it is free of preservatives and other substances that might inactivate the vaccine {01}.

0.7 mL of the diluent should be withdrawn into the syringe {01}. All of the diluent should be injected into the vial of lyophilized vaccine and agitated to mix thoroughly {01}. The entire contents should then be withdrawn into the syringe and the total volume of restored vaccine injected subcutaneously {01}.

Stability:
Varicella virus vaccine live has a potency level of 1500 PFU or higher per dose for at least 18 months in a frost-free freezer with an average temperature of -15 °C (+5 °F) or colder {01}. The vaccine has a minimum potency level of 1350 PFU after reconstitution and should be administered immediately after reconstitution {01}. The vaccine should be discarded if not used within 30 minutes after reconstitution {01}. The reconstituted vaccine should not be frozen {01}.

Incompatibilities:
Preservatives or other substances may inactivate the vaccine; therefore, only the diluent supplied by the manufacturer should be used for reconstitution {01}.

A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and reconstitution of the vaccine, since these substances may inactivate the live virus vaccine {01}.

Auxiliary labeling:
   • Keep frozen {01}.
   • Discard reconstituted vaccine if not used within 30 minutes {01}.

Note: The date and time of reconstitution should be indicated on the vial if the vaccine is not used immediately {01}.




Developed: 12/01/1998



References
  1. Varivax package insert (Merck—US), Rev 6/96, Rec 5/97.
  1. Centers for Disease Control and Prevention (CDC). Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 1996; 45(RR-11): 1-37.
  1. American Academy of Pediatrics (AAP). Committee on Infectious Diseases. Recommendations for the use of live attenuated varicella vaccine. Pediatrics 1995; 95(5): 791-6.
  1. American Academy of Pediatrics. Varicella zoster infections. In: Peter G, editor. 1997 Red book: report of the Committee on Infectious Diseases. 24th ed. Elk Grove Village, IL: American Academy of Pediatrics; 1997. p. 573-85.
  1. Centers for Disease Control and Prevention (CDC). Establishment of Varivax pregnancy registry. MMWR Morb Mortal Wkly Rep 1996; 45(11): 239.
  1. Zimmerman RK. Varicella vaccine: rationale and indications for use. Am Fam Physician 1996; 53(2): 647-51.
  1. Fisher M. Treatment of anaphylaxis. BMJ 1995; 311: 731-3.
  1. Gershon AA, Steinberg SP, LaRussa P, et al. Immunization of healthy adults with live attenuated varicella vaccine. J Infect Dis 1988; 158(1): 132-7.
  1. White CJ, Kuter BJ, Hildebrand CS, et al. Varicella vaccine (Varivax) in healthy children and adolescents: results from clinical trials, 1987 to 1989. Pediatrics 1991; 87(5): 604-10.
  1. Cat LK, Yamauchi NK. Varicella vaccine in immunocompromised patients. Ann Pharmacother 1996; 30: 181-4.
  1. Reviewer's comment, 9/98.
  1. Reviewer's comment, 9/98.
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