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Varivax

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Varivax

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

DRUG 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.

Last reviewed on RxList: 10/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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