Drugs Details

Drugs Info of Varivax
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Jun 2015 07:43 am
  • Brand Name : Varivax
  • Generic Name : varicella virus (chickenpox) vaccine (Pronunciation: VAR i SEL a VYE rus vax EEN)
Descriptions

VARIVAX* [Varicella Virus Vaccine Live (Oka/Merck)] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. 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 finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.

VARIVAX (varicella virus vaccine live) , when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains the following: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes, approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg sodium chloride, 0.5 mg monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, 0.08 mg of potassium chloride; residual components of MRC-5 cells including DNA and protein; and trace quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum. The product contains no preservative.

To maintain potency, the lyophilized vaccine must be kept frozen at an average temperature of -15°C (+5°F) or colder and must be used before the expiration date (see HOW SUPPLIED, Stability and Storage). Storage in any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C (+5°F) or colder and has a separate sealed freezer door is acceptable.

What are the possible side effects of this vaccine (Varivax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any...

Read All Potential Side Effects and See Pictures of Varivax »

What are the precautions when taking varicella virus vaccine live (Varivax)?

Before receiving varicella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: illness with a high fever over 101 degrees F (38 degrees C), immune system problems (such as due to HIV infection, cancer treatment, organ transplant), decreased immune function from other medications (see also Drug Interactions), untreated tuberculosis (TB) infection.

There is a small risk that you may expose others to infection with chickenpox for up to 6 weeks after you...

Read All Potential Precautions of Varivax »


This monograph has been modified to include the generic and brand name in many instances.

Indications

VARIVAX (varicella virus vaccine live) is indicated for vaccination against varicella in individuals 12 months of age and older.

The duration of protection of VARIVAX (varicella virus vaccine live) is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination.26 In addition, a boost in antibody levels has been observed in vaccinees following exposure to natural varicella as well as following a second dose of VARIVAX (varicella virus vaccine live) .5

In a highly vaccinated population, immunity for some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology. Post-marketing surveillance studies are ongoing to evaluate the need and timing for booster vaccination.

Vaccination with VARIVAX (varicella virus vaccine live) may not result in protection of all healthy, susceptible children, adolescents, and adults (see CLINICAL PHARMACOLOGY).

Dosage Administration

FOR SUBCUTANEOUS ADMINISTRATION

Do not inject intravascularly

Children

Children 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously. If a second 0.5-mL dose is administered, it should be given a minimum of 3 months later.

Adolescents and Adults

Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at elected date and a second 0.5-mL dose 4 to 8 weeks later.

VARIVAX (varicella virus vaccine live) is for subcutaneous administration. The outer aspect of the upper arm (deltoid) is the preferred site of injection.

VARIVAX (varicella virus vaccine live) SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection (see HOW SUPPLIED, Storage). Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C and has a separate sealed freezer door is acceptable for storing VARIVAX (varicella virus vaccine live) . The diluent should be stored separately at room temperature or in the refrigerator. To reconstitute the vaccine, first withdraw 0.7 mL of diluent into a syringe. Inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid) or the anterolateral thigh. IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of VARIVAX (varicella virus vaccine live) because these substances may inactivate the vaccine virus.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

To reconstitute the vaccine, use only the Merck sterile diluent supplied with VARIVAX (varicella virus vaccine live) , M-M-R II, or the component vaccines of M-M-R II, since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus.

Do not freeze reconstituted vaccine.

Do not give immune globulin, including Varicella Zoster Immune Globulin, concurrently with VARIVAX (see also PRECAUTIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX (varicella virus vaccine live) when reconstituted is a clear, colorless to pale yellow liquid.

How Supplied

No. 4826/4309 — VARIVAX (varicella virus vaccine live) is supplied as follows: (1) a single-dose vial of lyophilized vaccine, NDC 0006-4826-00 (package A); and (2) a box of 10 vials of diluent (package B).

No. 4827/4309 — VARIVAX (varicella virus vaccine live) is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00; and (2) a box of 10 vials of diluent (package B).

Stability

VARIVAX (varicella virus vaccine live) retains a potency level of 1500 PFU or higher per dose for at least 24 months in a frost-free freezer with an average temperature of -15°C (+5°F) or colder.

VARIVAX (varicella virus vaccine live) has a minimum potency level of approximately 1350 PFU 30 minutes after reconstitution at room temperature (20-25°C, 68-77°F).

Prior to reconstitution, VARIVAX (varicella virus vaccine live) retains potency when stored for up to 72 continuous hours at refrigerator temperature (2-8°C, 36-46°F).

For information regarding stability under conditions other than those recommended, call

1-800-9-VARIVAX (varicella virus vaccine live) .

Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -15°C (+5°F) or colder.

Before reconstitution, store the lyophilized vaccine in a freezer at an average temperature of -15°C (+5°F) or colder. Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C and has a separate sealed freezer door is acceptable for storing VARIVAX (varicella virus vaccine live) .

VARIVAX (varicella virus vaccine live) may be stored at refrigerator temperature (2-8°C, 36-46°F) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2-8°C which is not used within 72 hours of removal from -15°C storage should be discarded.

Before reconstitution, protect from light.

The diluent should be stored separately at room temperature (20-25°C, 68-77°F), or in the refrigerator.

REFERENCES

5. Unpublished data; files of Merck Research Laboratories.

Dist. by: MERCK & CO., INC., Whitehause Station, NJ 08889, USA. Issued March 2008. FDA rev date: n/a


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In clinical trials,4,5,9-15 VARIVAX (varicella virus vaccine live) was administered to over 11,000 healthy children, adolescents, and adults. VARIVAX (varicella virus vaccine live) was generally well tolerated.

In a double-blind, placebo-controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p < 0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site.4

Children 1 to 12 Years of Age

One-Dose Regimen in Children

In clinical trials involving healthy children monitored for up to 42 days after a single dose of VARIVAX (varicella virus vaccine live) , the frequency of fever, injection-site complaints, or rashes were reported as follows:

Table 1
Fever, Local Reactions, or Rashes (%) in Children
0 to 42 Days Post vaccination

Reaction N Post Dose 1 Peak Occurrence in Post vaccination Days
Fever ≥ 102°F (39°C) Oral 8827 14.7% 0-42
Injection-site complaints (pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness) 8916 19.3% 0-2
Varicella-like rash (injection site) 8916 3.4% 8-19
    Median number of lesions   2  
Varicella-like rash (generalized) 8916 3.8% 5-26
    Median number of lesions   5  

In addition, the most frequently ( ≥ 1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching.

Pneumonitis has been reported rarely ( < 1%) in children vaccinated with VARIVAX (varicella virus vaccine live) ; a causal relationship has not been established.

Febrile seizures have occurred rarely ( < 0.1%) in children vaccinated with VARIVAX (varicella virus vaccine live) ; a causal relationship has not been established. Two-Dose Regimen in Children

Nine hundred eighty-one (981) subjects in a clinical trial received 2 doses of VARIVAX (varicella virus vaccine live) 3 months apart and were actively followed for 42 days after each dose. The 2-dose regimen of varicella vaccine was generally well tolerated, with a safety profile generally comparable to that of the 1-dose regimen. The incidence of injection-site clinical complaints (primarily erythema and swelling) observed in the first 4 days following vaccination was slightly higher Postdose 2 (overall incidence 25.4%) than Postdose 1 (overall incidence 21.7%), whereas the incidence of systemic clinical complaints in the 42-day follow-up period was lower Postdose 2 (66.3%) than Postdose 1 (85.8%). Adolescents and Adults 13 Years of Age and Older

In clinical trials involving healthy adolescents and adults, the majority of whom received two doses of VARIVAX (varicella virus vaccine live) and were monitored for up to 42 days after any dose, the frequency of fever, injection-site complaints, or rashes were reported as follows:

Table 2
Fever, Local Reactions, or Rashes (%) in Adolescents and Adults
0 to 42 Days Post vaccination

Reaction N Post Dose 1 Peak Occurrence in Post vaccination Days N Post Dose 2 Peak Occurrence in Post vaccination Days
Fever ≥ 100°F (37.7°C) Oral 1584 10.2% 14-27 956 9.5% 0-42
Injection-site complaints (soreness, erythema, swelling, rash, pruritus, pyrexia, hematoma, induration, numbness) 1606 24.4% 0-2 955 32.5% 0-2
Varicella-like rash (injection site) 1606 3% 6-20 955 1% 0-6
     Median number of lesions   2     2  
Varicella-like rash (generalized) 1606 5.5% 7-21 955 0.9% 0-23
     Median number of lesions   5     5.5  

In addition, the most frequently ( ≥ 1%) reported adverse experiences, without regard to causality, are listed in decreasing order of frequency: upper respiratory illness, headache, fatigue, cough, myalgia, disturbed sleep, nausea, malaise, diarrhea, stiff neck, irritability/nervousness, lymphadenopathy, chills, eye complaints, abdominal pain, loss of appetite, arthralgia, otitis, itching, vomiting, other rashes, constipation, lower respiratory illness, allergic reactions (including allergic rash, hives), contact rash, cold/canker sore.

As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials.

The following additional adverse reactions have been reported since the vaccine has been marketed:

Body as a Whole

Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, anaphylaxis in individuals with or without an allergic history.

Hemic and Lymphatic System

Thrombocytopenia (including ITP).

Nervous/Psychiatric

Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barre syndrome; Bell's palsy; ataxia; non-febrile seizures; aseptic meningitis; dizziness; paresthesia.

Respiratory

Pharyngitis, Pneumonia/Pneumonitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; Henoch-Schonlein purpura; secondary bacterial infections of skin and soft tissue, including impetigo and cellulitis; herpes zoster.

Read the Varivax (varicella virus vaccine live) Side Effects Center for a complete guide to possible side effects

Interactions

See PRECAUTIONS, General, regarding the administration of immune globulins, salicylates, and transfusions.

Drug Interactions, Use with Other Vaccines

Results from clinical studies indicate that VARIVAX (varicella virus vaccine live) can be administered concomitantly with M-M-R II, COMVAX, or TETRAMUNE (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).

Limited data from an experimental product containing varicella vaccine suggest that VARIVAX (varicella virus vaccine live) can be administered concomitantly with DTaP (diphtheria, tetanus, acellular pertussis) and PedvaxHIB using separate sites and syringes (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).5 However, there are no data relating to simultaneous administration of VARIVAX (varicella virus vaccine live) with DTP or OPV.

REFERENCES

4. Weibel, R.E.; et al.: Live Attenuated Varicella Virus Vaccine, N Engl J Med. 370(22): 1409-1415, 1984.

5. Unpublished data; files of Merck Research Laboratories.

9. Arbeter, A.M.; et al.: Varicella Vaccine Trials in Healthy Children, A Summary of Comparative and Follow-up Studies, AJDC 138: 434-438, 1984.

10. Weibel, R.E.; et al.: Live Oka/Merck Varicella Vaccine in Healthy Children, JAMA 254(17): 2435-2439, 1985.

11. Chartrand, D.M.; et al.: New Varicella Vaccine Production Lots in Healthy Children and Adolescents, Abstracts of the 1988 Inter-Science Conference Antimicrobial Agents and Chemotherapy: 237(Abstract #731).

12. Johnson, C.E.; et al.: Live Attenuated Vaccine in Healthy 12 to 24 month old Children, Pediatrics 81: 512-518, 1988.

13. Gershon, A.A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine, J Infect Dis, 158(1): 132-137, 1988.

14. Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children, J Infect Dis, 161: 661-666, 1990.

15. White, C.J.; et al.: Varicella Vaccine (VARIVAX (varicella virus vaccine live) ) in Healthy Children and Adolescents: Results From Clinical Trials, 1987 to 1989, Pediatrics, 87(5): 604-610, 1991.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

General

Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactoid reaction occur.

The duration of protection from varicella infection after vaccination with VARIVAX (varicella virus vaccine live) is unknown.

It is not known whether VARIVAX (varicella virus vaccine live) given immediately after exposure to natural varicella virus will prevent illness.

Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin or varicella zoster immune globulin (VZIG).24

Following administration of VARIVAX (varicella virus vaccine live) , any immune globulin, including VZIG, should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination.24

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX (varicella virus vaccine live) as Reye's Syndrome has been reported following the use of salicylates during natural varicella infection (see CLINICAL PHARMACOLOGY, Reye's Syndrome).

The safety and efficacy of VARIVAX (varicella virus vaccine live) have not been established in children and young adults who are known to be infected with human immunodeficiency viruses with and without evidence of immunosuppression (see also CONTRAINDICATIONS).

Care is to be taken by the health care provider for safe and effective use of VARIVAX (varicella virus vaccine live) .

The health care provider should question the patient, parent, or guardian about reactions to a previous dose of VARIVAX (varicella virus vaccine live) or a similar product.

The health care provider should obtain the previous immunization history of the vaccinee.

VARIVAX (varicella virus vaccine live) should not be injected into a blood vessel.

Vaccination should be deferred in patients with a family history of congenital or hereditary immunodeficiency until the patient's own immune system has been evaluated.

A separate sterile needle and syringe should be used for administration of each dose of VARIVAX (varicella virus vaccine live) to prevent transfer of infectious diseases.

Needles should be disposed of properly and should not be recapped.

Transmission

Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

Therefore, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to six weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural varicella virus. Susceptible high-risk individuals include:

  • immunocompromised individuals
  • pregnant women without documented history of chickenpox or laboratory evidence of prior infection
  • newborn infants of mothers without documented history of chickenpox or laboratory evidence of prior infection.

Carcinogenesis, Mutagenesis, Impairment of Fertility

VARIVAX (varicella virus vaccine live) has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with VARIVAX (varicella virus vaccine live) . It is also not known whether VARIVAX (varicella virus vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, VARIVAX (varicella virus vaccine live) should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to VARIVAX (varicella virus vaccine live) . Patients and healthcare providers are encouraged to report any exposure to VARIVAX (varicella virus vaccine live) during pregnancy by calling (800) 986-8999.

Nursing Mothers

It is not known whether varicella vaccine virus is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if VARIVAX (varicella virus vaccine live) is administered to a nursing woman.

Geriatric Use

Clinical studies of VARIVAX (varicella virus vaccine live) did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

Pediatric Use

No clinical data are available on safety or efficacy of VARIVAX (varicella virus vaccine live) in children less than one year of age and administration to infants under twelve months of age is not recommended.

REFERENCE

24. Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 43(No. RR-1): 15-18, Jan. 28, 1994.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

A history of hypersensitivity to any component of the vaccine, including gelatin.

A history of anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains trace quantities of neomycin).

Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Individuals receiving immunosuppressive therapy. Individuals who are on immunosuppressant drugs are more susceptible to infections than healthy individuals. Vaccination with live attenuated varicella vaccine can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressant doses of corticosteroids.

Individuals with primary and acquired immunodeficiency states, including those who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency virus;23 cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

A family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.

Active untreated tuberculosis.

Any febrile respiratory illness or other active febrile infection.

Pregnancy; the possible effects of the vaccine on fetal development are unknown at this time. However, natural varicella is known to sometimes cause fetal harm. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (See PRECAUTIONS, Pregnancy).

REFERENCE

23. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy — Associated Virus, Ann Intern Med, 106: 75-78, 1987.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Varicella is a highly communicable disease in children, adolescents, and adults caused by the varicella-zoster virus (VZV). The disease usually consists of 300 to 500 maculopapular and/or vesicular lesions accompanied by a fever (oral temperature ≥ 100°F) in up to 70% of individuals.1,2 Approximately 3.5 million cases of varicella occurred annually from 1980-1994 in the United States with the peak incidence occurring in children five to nine years of age.3 The incidence rate of chickenpox in the total population was 8.3-9.1% per year in children 1-9 years of age before licensure of VARIVAX (varicella virus vaccine live) .4,6 The attack rate of natural varicella following household exposure among healthy susceptible children was shown to be 87% in unvaccinated populations.2 Although it is generally a benign, self-limiting disease, varicella may be associated with serious complications (e.g., bacterial superinfection, pneumonia, encephalitis, Reye's Syndrome), and/or death.

Evaluation of Clinical Efficacy Afforded by VARIVAX (varicella virus vaccine live)

The following section presents clinical efficacy data on a 1-dose regimen and a 2-dose regimen in children, and a 2-dose regimen in adolescents and adults.

Clinical Data in Children

One-Dose Regimen in Children

In combined clinical trials5 of VARIVAX (varicella virus vaccine live) at doses ranging from 1000-17,000 PFU, the majority of subjects who received VARIVAX (varicella virus vaccine live) and were exposed to wild-type virus were either completely protected from chickenpox or developed a milder form (for clinical description see below) of the disease. The protective efficacy of VARIVAX (varicella virus vaccine live) was evaluated in three different ways: 1) by comparing chickenpox rates in vaccinees versus historical controls, 2) by assessment of protection from disease following household exposure, and 3) by a placebo-controlled, double-blind clinical trial.

In early clinical trials,5 a total of 4240 children 1 to 12 years of age received 1000-1625 PFU of attenuated virus per dose of VARIVAX (varicella virus vaccine live) and have been followed for up to nine years post single-dose vaccination. In this group there was considerable variation in chickenpox rates among studies and study sites, and much of the reported data was acquired by passive follow-up. It was observed that 0.3%-3.8% of vaccinees per year reported chickenpox (called breakthrough cases). This represents an approximate 83% (95% confidence interval [CI], 82%, 84%) decrease from the age-adjusted expected incidence rates in susceptible subjects over this same period.19 In those who developed breakthrough chickenpox postvaccination, the majority experienced mild disease (median of the maximum number of lesions < 50). In one study, a total of 47% (27/58) of breakthrough cases had < 50 lesions compared with 8% (7/92) in unvaccinated individuals, and 7% (4/58) of breakthrough cases had > 300 lesions compared with 50% (46/92) in unvaccinated individuals.7

Among a subset of vaccinees who were actively followed in these early trials for up to nine years postvaccination, 179 individuals had household exposure to chickenpox. There were no reports of breakthrough chickenpox in 84% (150/179) of exposed children, while 16% (29/179) reported a mild form of chickenpox (38% [11/29] of the cases with a maximum total number of < 50 lesions; no individuals with > 300 lesions). This represents an 81% reduction in the expected number of varicella cases utilizing the historical attack rate of 87% following household exposure to chickenpox in unvaccinated individuals in the calculation of efficacy.

In later clinical trials5 with the current vaccine, a total of 1114 children 1 to 12 years of age received 2900-9000 PFU of attenuated virus per dose of VARIVAX (varicella virus vaccine live) and have been actively followed for up to 10 years post single-dose vaccination. It was observed that 0.2%-2.3% of vaccinees per year reported breakthrough chickenpox for up to 10 years post single-dose vaccination. This represents an estimated efficacy of 94% (95% CI, 93%, 96%), compared with the age-adjusted expected incidence rates in susceptible subjects over the same period.4,6,19 In those who developed breakthrough chickenpox postvaccination, the majority experienced mild disease, with the median of the maximum total number of lesions < 50. The severity of reported breakthrough chickenpox, as measured by number of lesions and maximum temperature, appeared not to increase with time since vaccination.

Among a subset of vaccinees who were actively followed in these later trials for up to 10 years postvaccination, 95 individuals were exposed to an unvaccinated individual with wild-type chickenpox in a household setting. There were no reports of breakthrough chickenpox in 92% (87/95) of exposed children, while 8% (8/95) reported a mild form of chickenpox (maximum total number of lesions < 50; observed range, 10 to 34). This represents an estimated efficacy of 90% (95% CI, 82%, 96%) based on the historical attack rate of 87% following household exposure to chickenpox in unvaccinated individuals in the calculation of efficacy.

Although no placebo-controlled trial was carried out with VARIVAX (varicella virus vaccine live) using the current vaccine, a placebo-controlled trial was conducted using a formulation containing 17,000 PFU per dose.4,8 In this trial, a single dose of VARIVAX (varicella virus vaccine live) protected 96-100% of children against chickenpox over a two-year period. The study enrolled healthy individuals 1 to 14 years of age (n=491 vaccine, n=465 placebo). In the first year, 8.5% of placebo recipients contracted chickenpox, while no vaccine recipient did, for a calculated protection rate of 100% during the first varicella season. In the second year, when only a subset of individuals agreed to remain in the blinded study (n=163 vaccine, n=161 placebo), 96% protective efficacy was calculated for the vaccine group as compared to placebo.

There are insufficient data to assess the rate of protection against the complications of chickenpox (e.g., encephalitis, hepatitis, pneumonia) in children.

Two-Dose Regimen in Children

In a clinical trial, a total of 2216 children 12 months to 12 years of age with a negative history of varicella were randomized to receive either 1 dose of VARIVAX (varicella virus vaccine live) (n=1114) or 2 doses of VARIVAX (varicella virus vaccine live) (n=1102) given 3 months apart. Subjects were actively followed for varicella, any varicella-like illness, or herpes zoster and any exposures to varicella or herpes zoster on an annual basis for 10 years after vaccination. Persistence of VZV antibody was measured annually for 9 years. Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.26 The estimated vaccine efficacy for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p < 0.001). This translates to a 3.4-fold lower risk of developing varicella > 42 days postvaccination during the 10-year observation period in children who received 2 doses than in those who received 1 dose (2.2% vs. 7.5%, respectively).

Clinical Data in Adolescents and Adults

Two-Dose Regimen in Adolescents and Adults

In early clinical trials, a total of 796 adolescents and adults received 905-1230 PFU of attenuated virus per dose of VARIVAX (varicella virus vaccine live) and have been followed for up to six years following 2-dose vaccination. A total of 50 clinical varicella cases were reported > 42 days following 2-dose vaccination. Based on passive follow-up, the annual chickenpox breakthrough event rate ranged from < 0.1% to 1.9%. The median of the maximum total number of lesions ranged from 15 to 42 per year.

Although no placebo-controlled trial was carried out in adolescents and adults, the protective efficacy of VARIVAX (varicella virus vaccine live) was determined by evaluation of protection when vaccinees received 2 doses of VARIVAX (varicella virus vaccine live) 4 or 8 weeks apart and were subsequently exposed to chickenpox in a household setting.5 Among the subset of vaccinees who were actively followed in these early trials for up to six years, 76 individuals had household exposure to chickenpox. There were no reports of breakthrough chickenpox in 83% (63/76) of exposed vaccinees, while 17% (13/76) reported a mild form of chickenpox. Among 13 vaccinated individuals who developed breakthrough chickenpox after a household exposure, 62% (8/13) of the cases reported maximum total number of lesions < 50, while no individual reported > 75 lesions. The attack rate of unvaccinated adults exposed to a single contact in a household has not been previously studied. Utilizing the previously reported historical attack rate of 87% for natural varicella following household exposure to chickenpox among unvaccinated children in the calculation of efficacy, this represents an approximate 80% reduction in the expected number of cases in the household setting.

In later clinical trials, a total of 220 adolescents and adults received 3315-9000 PFU of attenuated virus per dose of VARIVAX (varicella virus vaccine live) and have been actively followed for up to six years following 2-dose vaccination. A total of 3 clinical varicella cases were reported > 42 days following 2-dose vaccination. Two cases reported < 50 lesions and none reported > 75. The annual chickenpox breakthrough event rate ranged from 0% to 1.2%. Among the subset of vaccinees who were actively followed in these later trials for up to five years, 16 individuals were exposed to an unvaccinated individual with wild-type chickenpox in a household setting. There were no reports of breakthrough chickenpox among the exposed vaccinees.

There are insufficient data to assess the rate of protection of VARIVAX (varicella virus vaccine live) against the serious complications of chickenpox in adults (e.g., encephalitis, hepatitis, pneumonitis) and during pregnancy (congenital varicella syndrome).

Immunogenicity of VARIVAX (varicella virus vaccine live)

The following section presents immunogenicity data on a 1-dose regimen and a 2-dose regimen in children, and a 2-dose regimen in adolescents and adults.

One-Dose Regimen in Children

Clinical trials with several formulations of the vaccine containing attenuated virus ranging from 1000 to 17,000 PFU per dose have demonstrated that VARIVAX (varicella virus vaccine live) induces detectable immune responses in a high proportion of individuals and is generally well tolerated in healthy individuals ranging from 12 months to 55 years of age.4,5,9-15

Seroconversion is defined by the acquisition of any detectable VZV antibodies, based on an optical density (OD) cutoff, corresponding approximately to a lower limit of 0.6 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL.

The gpELISA is a highly sensitive assay that is not commercially available. Seroconversion was observed in 97% of vaccinees at approximately 4-6 weeks postvaccination in 6889 susceptible children 12 months to 12 years of age. Rates of breakthrough disease were significantly lower among children with VZV antibody titers ≥ 5 gpELISA units/mL compared with children with titers < 5 gpELISA units/mL. Titers ≥ 5 gpELISA units/mL were induced in approximately 76% of children vaccinated with a single dose of vaccine at 1000-17,000 PFU per dose.

VARIVAX (varicella virus vaccine live) also induces cell-mediated immune responses in vaccinees. The relative contributions of humoral immunity and cell-mediated immunity to protection from chickenpox are unknown.

Two-Dose Regimen in Children

In a multicenter study, healthy children 12 months to 12 years of age received either 1 dose of VARIVAX (varicella virus vaccine live) or 2 doses administered 3 months apart. The immunogenicity results are shown in the following table.

  VARIVAX VARIVAX
  1-Dose Regimen
(N = 1114)
2-Dose Regimen
(N = 1102)
6 Weeks Post vaccination 6 Weeks Post dose 1 6 Weeks Post dose 2
Seroconversion Rate 98.9% (882/892) 99.5% (847/851) 99.9% (768/769)
Percent with VZV Antibody Titer ≥ 5 gpELISA units/mL 84.9% (757/892) 87.3% (743/851) 99.5% (765/769)
Geometric mean titers (gpELISA units/mL) 12.0 12.8 141.5

The results from this study and other studies in which a second dose of vaccine was administered 3 to 6 years after the initial dose demonstrate significant boosting of the VZV antibody response with a second dose. VZV antibody levels after 2 doses given 3 to 6 years apart are comparable to those obtained when the 2 doses are given 3 months apart.

Two-Dose Regimen in Adolescents and Adults

In a multicenter study involving susceptible adolescents and adults 13 years of age and older, 2 doses of VARIVAX (varicella virus vaccine live) administered 4 to 8 weeks apart induced a seroconversion rate of approximately 75% in 539 individuals 4 weeks after the first dose and of 99% in 479 individuals 4 weeks after the second dose. The average antibody response in vaccinees who received the second dose 8 weeks after the first dose was higher than that in vaccinees who received the second dose 4 weeks after the first dose. In another multicenter study involving adolescents and adults, 2 doses of VARIVAX (varicella virus vaccine live) administered 8 weeks apart induced a seroconversion rate of 94% in 142 individuals 6 weeks after the first dose and 99% in 122 individuals 6 weeks after the second dose.

Persistence of Immune Response

The following section presents immune persistence data on a 1-dose regimen and a 2-dose regimen in children, and a 2-dose regimen in adolescents and adults.

One-Dose Regimen in Children

In clinical studies involving healthy children who received 1 dose of vaccine, detectable VZV antibodies were present in 99.0% (3886/3926) at 1 year, 99.3% (1555/1566) at 2 years, 98.6% (1106/1122) at 3 years, and 99.4% (1168/1175) at 4 years, 99.2% (737/743) at 5 years, 100% (142/142) at 6 years, 97.4% (38/39) at 7 years, 100% (34/34) at 8 years, and 100% (16/16) at 10 years postvaccination.

Two-Dose Regimen in Children

In recipients of 1 dose of VARIVAX (varicella virus vaccine live) over 9 years of follow-up, the geometric mean titer (GMT) and the percent of subjects with VZV antibody titers ≥ 5 gpELISA units/mL generally increased. The GMTs and percent of subjects with VZV antibody titers ≥ 5 gpELISA units/mL in the 2-dose recipients were higher than those in the 1-dose recipients for the first year of follow-up and generally comparable thereafter. The cumulative rate of VZV antibody persistence with both regimens remained very high at year 9 (99.0% for the 1-dose group and 98.8% for the 2-dose group).

Two-Dose Regimen in Adolescents and Adults

In clinical studies involving healthy adolescents and adults who received 2 doses of vaccine, detectable VZV antibodies were present in 97.9% (568/580) at 1 year, 97.1% (34/35) at 2 years, 100% (144/144) at 3 years, 97.0% (98/101) at 4 years, 97.4% (76/78) at 5 years, and 100% (34/34) at 6 years postvaccination.

A boost in antibody levels has been observed in vaccinees following exposure to natural varicella which could account for the apparent long-term persistence of antibody levels after vaccination in these studies. The duration of protection from varicella obtained using VARIVAX (varicella virus vaccine live) in the absence of wild-type boosting is unknown. VARIVAX (varicella virus vaccine live) also induces cell-mediated immune responses in vaccinees. The relative contributions of humoral immunity and cell-mediated immunity to protection from chickenpox are unknown.

Transmission

In the placebo-controlled trial, transmission of vaccine virus was assessed in household settings (during the 8-week postvaccination period) in 416 susceptible placebo recipients who were household contacts of 445 vaccine recipients. Of the 416 placebo recipients, three developed chickenpox and seroconverted, nine reported a varicella-like rash and did not seroconvert, and six had no rash but seroconverted. If vaccine virus transmission occurred, it did so at a very low rate and possibly without recognizable clinical disease in contacts. These cases may represent either natural varicella from community contacts or a low incidence of transmission of vaccine virus from vaccinated contacts (see PRECAUTIONS, Transmission).4,16 Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

Herpes Zoster

Overall, 9454 healthy children (12 months to 12 years of age) and 1648 adolescents and adults (13 years of age and older) have been vaccinated with Oka/Merck live attenuated varicella vaccine in clinical trials. Eight cases of herpes zoster have been reported in children during 42,556 person years of follow-up in clinical trials, resulting in a calculated incidence of at least 18.8 cases per 100,000 person years. The completeness of this reporting has not been determined. One case of herpes zoster has been reported in the adolescent and adult age group during 5410 person years of follow-up in clinical trials resulting in a calculated incidence of 18.5 cases per 100,000 person years.5

All nine cases were mild and without sequelae. Two cultures (one child and one adult) obtained from vesicles were positive for wild-type VZV as confirmed by restriction endonuclease analysis.5,17 The long-term effect of VARIVAX (varicella virus vaccine live) on the incidence of herpes zoster, particularly in those vaccinees exposed to natural varicella, is unknown at present.

In children, the reported rate of herpes zoster in vaccine recipients appears not to exceed that previously determined in a population-based study of healthy children who had experienced natural varicella.5,18,19 The incidence of herpes zoster in adults who have had natural varicella infection is higher than that in children.20

Reye's Syndrome

Reye's Syndrome has occurred in children and adolescents following natural varicella infection, the majority of whom had received salicylates.21 In clinical studies in healthy children and adolescents in the United States, physicians advised varicella vaccine recipients not to use salicylates for six weeks after vaccination. There were no reports of Reye's Syndrome in varicella vaccine recipients during these studies.

Studies with Other Vaccines

In combined clinical studies involving 1080 children 12 to 36 months of age, 653 received VARIVAX (varicella virus vaccine live) and M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live) concomitantly at separate sites and 427 received the vaccines six weeks apart. Seroconversion rates and antibody levels were comparable between the two groups at approximately six weeks post-vaccination to each of the virus vaccine components. No differences were noted in adverse reactions reported in those who received VARIVAX (varicella virus vaccine live) concomitantly with M-M-R II at separate sites and those who received VARIVAX (varicella virus vaccine live) and M-M-R II at different times (see PRECAUTIONS: DRUG INTERACTIONS, Use with Other Vaccines).5

In a clinical study involving 318 children 12 months to 42 months of age, 160 received an investigational vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with booster doses of DTaP (diphtheria, tetanus, acellular pertussis) and OPV (oral poliovirus vaccine) while 144 received M-M-R II concomitantly with booster doses of DTaP and OPV followed by VARIVAX (varicella virus vaccine live) 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and VZV and the percentage of vaccinees whose titers were boosted for diphtheria, tetanus, pertussis, and polio were comparable between the two groups, but anti-VZV levels were decreased when the investigational vaccine containing varicella was administered concomitantly with DTaP. No clinically significant differences were noted in adverse reactions between the two groups.5

In another clinical study involving 307 children 12 to 18 months of age, 150 received an investigational vaccine (a formulation combining measles, mumps, rubella, and varicella in one syringe) concomitantly with a booster dose of PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] while 130 received M-M-R II concomitantly with a booster dose of PedvaxHIB followed by VARIVAX (varicella virus vaccine live) 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella, and VZV, and geometric mean titers for PedvaxHIB were comparable between the two groups, but anti-VZV levels were decreased when the investigational vaccine containing varicella was administered concomitantly with PedvaxHIB. No clinically significant differences in adverse reactions were seen between the two groups.5

In a clinica[study involving 609 children 12 to 23 months of age, 305 received VARIVAX (varicella virus vaccine live) , M-M-R II, and TETRAMUNE** (Haemophilus influenzae type b, diphtheria, tetanus, and pertussis vaccines) concomitantly at separate sites, and 304 received M-M-R II and TETRAMUNE concomitantly at separate sites, followed by VARIVAX (varicella virus vaccine live) 6 weeks later. At six weeks postvaccination, seroconversion rates for measles, mumps, rubella and VZV were similar between the two groups. Postvaccination GMTs for all antigens were similar in both treatment groups except for VZV, which was lower when VARIVAX (varicella virus vaccine live) was administered concomitantly with M-M-R II and TETRAMUNE, but within the range of GMTs seen in previous clinical experience when VARIVAX (varicella virus vaccine live) was administered alone. At 1 year postvaccination, GMTs for measles, mumps, rubella, VZV and Haemophilus influenzae type b were similar between the two groups. All three vaccines were well tolerated regardless of whether they were administered concomitantly at separate sites or 6 weeks apart. There were no clinically important differences in reaction rates when the three vaccines were administered concomitantly versus 6 weeks apart.

In a clinical study involving 822 children 12 to 15 months of age, 410 received COMVAX* [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) vaccine], M-M-R II, and VARIVAX (varicella virus vaccine live) concomitantly at separate sites, and 412 received COMVAX followed by M-M-R II and VARIVAX (varicella virus vaccine live) given concomitantly at separate sites, 6 weeks later. At six weeks postvaccination, the immune responses for the subjects who received the concomitant doses of COMVAX, M-M-R II, and VARIVAX (varicella virus vaccine live) were similar to those of the subjects who received COMVAX followed 6 weeks later by M-M-R II and VARIVAX (varicella virus vaccine live) with respect to all antigens administered. All three vaccines were generally well tolerated regardless of whether they were administered concomitantly at separate sites or 6 weeks apart. There were no clinically important differences in reaction rates when the three vaccines were administered concomitantly versus 6 weeks apart.

VARIVAX (varicella virus vaccine live) is recommended for subcutaneous administration. However, during clinical trials, some children received VARIVAX (varicella virus vaccine live) intramuscularly resulting in seroconversion rates similar to those in children who received the vaccine by the subcutaneous route.22 Persistence of antibody and efficacy in those receiving intramuscular doses have not been defined.

REFERENCES

1. Balfour, H.H.; et al.: Acyclovir Treatment of Varicella in Otherwise Healthy Children, Pediatrics., 116: 633-639, 1990.

2. Ross, A.H.: Modification of Chickenpox in Family Contacts by Administration of Gamma Globulin, N Engl J Med. 267: 369-376, 1962.

3. Preblud, S.R.: Varicella: Complications and Costs, Pediatrics, 78(4 Pt 2): 728-735, 1986.

4. Weibel, R.E.; et al.: Live Attenuated Varicella Virus Vaccine, N Engl J Med. 370(22): 1409-1415, 1984.

5. Unpublished data; files of Merck Research Laboratories.

6. Wharton, M.; et al.: Health Impact of Varicella in the 1980's. Thirtieth Interscience Conference on Antimicrobial Agents and Chemotherapy, (Abstract #1138), 1990.

7. Bernstein, H.H.; et al.: Clinical Survey of Natural Varicella Compared with Breakthrough Varicella After Immunization with Live Attenuated Oka/Merck Varicella Vaccine. Pediatrics 92: 833-837, 1993.

8. Kuter, B.J.; et al.: Oka/Merck Varicella Vaccine in Healthy Children: Final Report of a 2-Year Efficacy Study and 7-Year Follow-up Studies, Vaccine, 9: 643-647, 1991.

9. Arbeter, A.M.; et al.: Varicella Vaccine Trials in Healthy Children, A Summary of Comparative and Follow-up Studies, AJDC 138: 434-438, 1984.

10. Weibel, R.E.; et al.: Live Oka/Merck Varicella Vaccine in Healthy Children, JAMA 254(17): 2435-2439, 1985.

11. Chartrand, D.M.; et al.: New Varicella Vaccine Production Lots in Healthy Children and Adolescents, Abstracts of the 1988 Inter-Science Conference Antimicrobial Agents and Chemotherapy: 237(Abstract #731).

12. Johnson, C.E.; et al.: Live Attenuated Vaccine in Healthy 12 to 24 month old Children, Pediatrics 81: 512-518, 1988.

13. Gershon, A.A.; et al.: Immunization of Healthy Adults with Live Attenuated Varicella Vaccine, J Infect Dis, 158(1): 132-137, 1988.

14. Gershon, A.A.; et al.: Live Attenuated Varicella Vaccine: Protection in Healthy Adults Compared with Leukemic Children, J Infect Dis, 161: 661-666, 1990.

15. White, C.J.; et al.: Varicella Vaccine (VARIVAX (varicella virus vaccine live) ) in Healthy Children and Adolescents: Results From Clinical Trials, 1987 to 1989, Pediatrics, 87(5): 604-610, 1991.

16. Asano, Y.; et al.: Contact Infection from Live Varicella Vaccine Recipients, Lancet 1(7966): 965, 1976.

17. Hammerschlag, M.R.; et al.: Herpes Zoster in an Adult Recipient of Live Attenuated Varicella Vaccine, J Infect Dis 160(3): 535-537, 1989.

18. White, C.J.: Letters to the Editor, Pediatrics 318: 354, 1992.

19. Guess, H.A.; et al.: Population-Based Studies of Varicella Complications, Pediatrics 78(4 Pt 2): 723-727, 1986.

20. Ragozzino, M.; et al.: Population-Based Study of Herpes Zoster and Its Sequelae, Medicine 61(5): 310-316, 1982.

21. Morbidity and Mortality Weekly Report 34(1): 13-16, Jan. 11, 1985.

22. Dennehy, P.H.; et al.: Immunogenicity of Subcutaneous Versus Intramuscular Oka/Merck Varicella Vaccination in Healthy Children, Pediatrics 88(3): 604-607, 1991.

23. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy — Associated Virus, Ann Intern Med, 106: 75-78, 1987.

24. Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 43(No. RR-1): 15-18, Jan. 28, 1994.

25. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, 1990.

26. Kuter, B.J.; et al.: Ten Year Follow-up of Healthy Children who Received One or Two Injections of Varicella Vaccine, Pediatr Infect Dis J, 23:132-37, 2004.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

The health care provider should inform the patient, parent, or guardian of the benefits and risks of VARIVAX (varicella virus vaccine live) .

Patients, parents, or guardians should be instructed to report any adverse reactions to their health care provider.

The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.25 The VAERS toll-free number for VAERS forms and information is 1-800-822-7967.

Pregnancy should be avoided for three months following vaccination.

REFERENCE

25. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, 1990.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

VARICELLA VIRUS VACCINE (CHICKENPOX) - INJECTION

 

(VAR-i-SEL-a)

 

COMMON BRAND NAME(S): Varivax

 

USES: This medication is used to help prevent varicella virus infection (commonly known as chickenpox). Chickenpox is a common childhood illness, but can cause more serious illnesses in people who have not yet had either chickenpox or this vaccine. Serious (rarely fatal) problems (such as pneumonia and inflammation of the liver or brain) may rarely occur from this infection, and first-time infections in adults may be very severe. It may also cause a very serious brain/liver condition called Reyes syndrome in children or teenagers. If you are infected while pregnant, your unborn infant may be harmed. Vaccination during childhood may help prevent this infection and the problems that can occur.

The virus in this vaccine is alive, but it has been weakened (attenuated) and therefore has a decreased ability to cause illness. It works by helping the body produce immunity (protection) that will prevent you from getting chickenpox, or will lessen the seriousness of the infection. As with any vaccine, it may not fully protect everyone who receives it. People who get chickenpox after getting the vaccine usually have mild cases with fewer blisters, fewer fevers, and faster recoveries.

The vaccine is recommended for children 12 months and older and adults who have not had chickenpox or received a varicella vaccination before.

 

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, ask your health care provider.

This vaccine is usually given by injection under the skin by a health care professional.

Children aged 12 months to 12 years should receive 2 doses at least 3 months apart. Teenagers 13 years and older and adults who are not immune to the virus should receive 2 doses 4 to 8 weeks apart.

Consumer Overview Side Effect

SIDE EFFECTS: Pain/redness/bruising/swelling at the injection site, fever, or mild chickenpox-like rash may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. However, report all side effects to the doctor.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

 

Read the Varivax (varicella virus vaccine live) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before receiving varicella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: illness with a high fever over 101 degrees F (38 degrees C), immune system problems (such as due to HIV infection, cancer treatment, organ transplant), decreased immune function from other medications (see also Drug Interactions), untreated tuberculosis (TB) infection.

There is a small risk that you may expose others to infection with chickenpox for up to 6 weeks after you have been vaccinated. You should avoid being in the same room with people with immune system problems, pregnant women who have not had chickenpox, children/partners of mothers who have not had chickenpox, and newborn babies born at less than 28 weeks of pregnancy.

This medication must not be used during pregnancy. There is some risk that it may harm an unborn baby. If you have been vaccinated with varicella virus vaccine, you should not become pregnant for at least 3 months after the vaccination. Discuss the possible risks with your doctor.

It is unknown if the varicella virus in this vaccine passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some of the products that may interact with this drug include: chemotherapy, corticosteroids (such as prednisone, dexamethasone), drugs that lower the immune system (such as cyclosporine, tacrolimus, mycophenolate), certain antiviral drugs (such as acyclovir, famciclovir, and valacyclovir).

All children and teenagers should avoid aspirin or aspirin-like medications (such as salsalate) for 6 weeks after vaccination.

Postpone vaccination with varicella vaccine for at least 5 months if you have received a blood transfusion or other blood products (such as immune globulin, varicella zoster immune globulin). You may not develop enough antibodies to protect you from infection.

Other vaccines may be given at the same time as this vaccine, but they should be given with separate syringes and at different injection sites.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Keep vaccine records for yourself and all of your children, and after your children are grown, give the records to them and their doctors. This will prevent unnecessary re-vaccinations.

 

MISSED DOSE: It is important that you receive each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember. If you miss an appointment, contact the doctor for advice.

 

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Varivax

Generic Name: varicella virus (chickenpox) vaccine (Pronunciation: VAR i SEL a VYE rus vax EEN)

  • What is varicella virus vaccine (Varivax)?
  • What are the possible side effects of this vaccine (Varivax)?
  • What is the most important information I should know about this vaccine (Varivax)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Varivax)?
  • How is this vaccine given (Varivax)?
  • What happens if I miss a dose (Varivax)?
  • What happens if I overdose (Varivax)?
  • What should I avoid before or after receiving this vaccine (Varivax)?
  • What other drugs will affect varicella virus vaccine (Varivax)?
  • Where can I get more information?

What is varicella virus vaccine (Varivax)?

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster.

Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Chickenpox is spread from person to person through the air, or by coming into contact with the fluid from a chickenpox blister.

Varicella virus vaccine is for use in adults and children who are at least 12 months old.

This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the varicella virus vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Varivax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • cough, tight feeling in your chest, breathing problems;
  • seizure (black-out or convulsions);
  • easy bruising or bleeding, unusual weakness;
  • behavior changes; or
  • high fever (within a few hours or a few weeks after the vaccine).

Less serious side effects include:

  • redness, pain, or swelling where the shot was given;
  • low fever;
  • mild skin rash;
  • runny or stuffy nose, cough, sore throat;
  • headache, tired feeling;
  • sleep problems (insomnia);
  • joint or muscle pain; or
  • nausea, vomiting, stomach pain, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Varivax (varicella virus vaccine live) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about this vaccine (Varivax)?

The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.

If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Do not give salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others to a child under 18 for at least 6 weeks after he or she has received varicella vaccine. A serious condition called Reye's Syndrome has been reported in young people with chickenpox who take aspirin or salicylates.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers
  • Varivax

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving this vaccine (Varivax)?

You should not receive this vaccine if you are allergic to gelatin, neomycin (Mycifradin, Neo-Fradin, Neo-Tab), or if you have ever had a life-threatening allergic reaction to any vaccine containing varicella.

You should also not receive this vaccine if you have:

  • active tuberculosis infection that is not being treated;
  • a history of Guillain-Barré syndrome;
  • a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or blood cell disorder such as anemia;
  • if you or someone in your household has severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;
  • if you are under 18 years old and have recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;
  • if you have recently received a stem cell transplant; or
  • if you are pregnant.

Before receiving varicella virus (Chickenpox) vaccine, talk to your doctor if you have:

  • thrombocytopenia purpura (easy bruising or bleeding);
  • active tuberculosis infection; or
  • if you have received an immune globulin or other blood product within the past year.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Avoid becoming pregnant for at least 3 months after receiving a varicella vaccine.

Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given (Varivax)?

This vaccine is given as an injection (shot) under the skin. You will receive this injection in a doctor's office or other clinic setting.

The varicella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 months old. The booster shot is then given at 4 to 6 years of age, or at least 3 months after the first dose.

If you are at least 13 years old and you have never had chickenpox or received this vaccine, you should receive two varicella virus vaccines at least 28 days apart.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who treats you if you have received a varicella virus vaccine within the past 4 to 6 weeks.

Side Effects Centers
  • Varivax

Patient Detailed Avoid Taking

What happens if I miss a dose (Varivax)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Varivax)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Varivax)?

For at least 6 weeks after receiving a varicella vaccine, avoid coming into contact with newborn infants, pregnant women who have never had chickenpox, and anyone who has a weak immune system. There is a chance that you could pass the virus to a person with a weak immune system or no immunity to chickenpox.

What other drugs will affect varicella virus vaccine (Varivax)?

Do not use salicylates (aspirin or aspirin containing products) for at least six weeks after receiving the vaccine. A serious condition called Reye's Syndrome has been reported in patients with chicken pox taking salicylates.

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Side Effects Centers
  • Varivax

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