Varicella

The Misunderstood Vaccine


Introduction/Review

·        Live, attenuated Varicella virus vaccine

·        Licensed March 1995 > 12 months of age

·        Secondary attack rates for this virus may reach 90%

·        Systemic infection, lifetime immunity, clinical illness after reexposure is rare

·        Wild-type varicella often leads to reinfection that boosts antibody titers

·        Remains dormant in sensory-nerve ganglia

·        In children 4-5 days and is characterized by fever, malaise

·        Generalized vesicular rash, 250-500 lesions, shawl distribution

·        Primary subclinical infection with VZV is rare


Epidemiology

·        Transmitted

o       direct contact, droplet, or aerosol from vesicular fluid of skin lesions

o       secretions from the respiratory tract

o       enters the host through the upper-respiratory tract

·        Incubation period for varicella is 14-16 days (range 10-21)

·        Incubation period for varicella is 14-16 days

·        Contagiousness: 1-2 days before the onset of rash until all lesions are crusted

·        Develops in nearly all persons who live in the United States

·        33% occurred in preschool-age children (1-4 years)

·        44% occurred in school-age children (5-9 years)

·        90% of cases in persons less than 15 years

·        Rate of complications higher > 15 years and < 1 year

o       Skin lesions (virulent strains of group A streptococci)

o       Pneumonia, dehydration, encephalitis, hepatitis

o       Reye syndrome unlikely if asa is avoided

·        Decrease in morbidity

o       the substantial reduction in cases of Reye syndrome

o       the availability of acyclovir

o       selective use of VZIG

o       improvements in supportive care

o       the risk for death increases with age


Prenatal and Perinatal Exposure

·        Intrauterine VZV infection

o       Congenital Varicella syndrome

o       Clinical newborn Varicella

o       Clinical zoster (infancy/early childhood)

·        Congenital varicella syndrome

o       13-20 weeks' gestation: low birthweight, cutaneous scarring, limb hypoplasia, microcephaly, cortical atrophy, chorioretinitis, cataracts, and other anomalies

·        Clinical newborn Varicella

o       5 days before to 2 days after delivery

o       infection in an estimated 17%-30%

o       exposed to VZV without sufficient maternal antibody to lessen the severity

o       risk for death: 31% among infants whose mothers had onset of rash 0-4 days prepartum

 


Nosocomial Transmission

o       Patients @ high risk for severe disease and complications

o       premature infants born to susceptible mothers

o       infants less than 28 weeks' gestation or less than or equal to 1,000

o       immunocompromised persons of all

o       Managing Outbreaks

o       Isolating patients and susceptibles

o       controlling air flow

o       using rapid serologic testing

o       furloughing or screening exposed

o       temporarily reassigning susceptible personnel


Herpes Zoster

o       VZV persists in a latent form in sensory-nerve ganglia

o       latent virus can be reactivated

o       15% of the population will experience herpes zoster

o       immunocompromised persons and the elderly

o       transmission of VZV from herpes zoster is much less than that from primary Varicella


VARICELLA ANTIBODY TESTING

o       adults who have negative histories are seropositive (71%-93%)

o       levels of antibody acquired from vaccination are lower

o       complement fixation (CF) – least sensitive, most widely used

o       Sensitive but usually impractical for clinical use

§        indirect fluorescent antibody (IFA)

§        radioimmunoassay (RIA)

§        fluorescent antibody to membrane antigen (FAMA)

§        neutralization (N)

o       indirect hemagglutination (IHA)

o       immune adherence hemagglutination (IAHA)

o       latex agglutination (LA)

§        not sensitive enough

o       enzyme-linked immunosorbent assay (ELISA)

§        not commercially available YET


ACYCLOVIR FOR THE TREATMENT AND PREVENTION OF Varicella

o       synthetic nucleoside analog

o       1992: FDA approved acyclovir for otherwise healthy children

o       Beneficial clinical effects

o       Decrease in the number of days in which new lesions appeared

o       The duration of fever

o       The severity of cutaneous and systemic signs and symptoms

o       Difficult to say if complications were decreased

o       Antibody titers were the same

o       Not enough benefit to justify the cough

o       Primary indication: adolescents in households of infected children

o       Category C in the FDA use-in-pregnancy rating

o       (risk cannot be ruled out, but potential benefits may justify the possible risk)

o       Prophylactic use of acyclovir

o       Prevent/modify clinical disease in most cases, some remained susceptible


LIVE, ATTENUATED VARICELLA VIRUS VACCINE

o       Oka strain isolated in Japan in the early 1970s

o       Sequential propagation in cultures, a total of 31 passages

o       Licensure was extended to healthy children in 1989

o       Contains: hydrolyzed gelatin, trace amounts of neomycin and fetal bovine serum, sucrose, and residual components of MRC-5, but no preservatives

o       Aprox 10,000 volunteers received it in trials


Immunogenicity

o       Seroconversion rate was demonstrated to be 97% (.3 U)

o       76% of these children achieved antibody titers to 5 U

o       Persistence of antibody was consistently high (i.e., greater than 90%)

o        7-10 years post immunization titers: comparable to those in children who had natural varicella infection 7-10 years earlier

o       20-year follow-up study revealed that antibody levels were higher than those observed 10 years earlier

o       > 13 years: 78% seroconverted after the 1st dose and 99% seroconverted after a 2nd


Efficacy and Breakthrough Infections

o       Efficacy and Breakthrough Infections

o       Breakthrough infections following exposure to wild-type virus

o       Efficacy among children 1-14 years

o       100% after the first varicella season and

o       96% after the second season

o       9 years Post vaccination: varicella developed in less than 1%-4.4% of vaccines/year

o       Substantially less severe among vaccinated persons than unvaccinated persons

o       Usually afebrile and < 50 lesions

o       Rate of disease transmission from vaccinees in whom varicella develops is low

o       Insufficient data to evaluate the extent of the protection provided by varicella vaccination against serious complications

o       Current research has not been affected by wide use of the vaccine

o       The extent to which the protection provided by vaccination has been increased by boosting from exposure to natural virus is unknown

o       Whether longer term immunity may wane as the circulation of natural VZV decreases is unknown


Transmission of Vaccine Virus

o       immunocompromised and associated with occurrence of rash

Herpes Zoster Following Vaccination

o       incidence after varicella vaccination: 18 per 100,000 person years

o       incidence after natural varicella infection among healthy children was 77 per 100,000 person years.

 

 

 

Vaccine as Postexposure Prophylaxis

o       2 studies

o       protective efficacy was greater than or equal to 90% when children were vaccinated within 3 days of exposure.


Cost Benefit of Vaccine

o       When only direct medical costs were considered, the benefit-cost ratio was 0.90:1

 

DISTRIBUTION, HANDLING, AND STORAGE OF VACCINE

o       Stored frozen at an average temperature of less than or equal to 5 F

o       Small, dormitory-style refrigerators may not meet temperature requirements

o       Discarded if not used within 30 minutes after reconstitution


RECOMMENDATIONS FOR THE USE OF VARICELLA VIRUS VACCINE

o       Persons less than 13 Years of Age

o       12 months-12 years of age: one 0.5-mL dose of vaccine subcutaneously

o       Children who have a reliable history of varicella are considered immune

o       Vaccine is well tolerated in seropositive persons

o       12-18 Months of Age

o       administered to all children at this age, regardless of history

o       at the same time as measles-mumps-rubella (MMR) vaccine

o       separate sites and with separate syringes

o       Persons greater than or equal to 13 Years of Age

o       two 0.5-mL doses of vaccine, subcutaneously, 4-8 weeks apart

o       serologic testing before vaccination is likely to be cost effective for adolescents


VACCINE-ASSOCIATED ADVERSE EVENTS

o       injection site: only significant adverse

o       pain/soreness, swelling, erythema, rash, pruritus, hematoma, induration, and stiffness

o       nonlocalized, varicella-like rash

o   Febrile seizures

CONTRAINDICATIONS AND PRECAUTIONS

o       Neomycin or gelatin allergy

o       Failure to vaccinate children with minor illnesses can impede vaccination efforts

o       Not recommended for persons who have untreated, active tuberculosis

o       Malignant condition, including blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems

o       Primary or acquired immunodeficiency

o       Conditions That Require Steroid Therapy

o       2 mg/kg of body weight or a total of 20 mg/day of prednisone

o       Withholding steroids for 2-3 weeks following vaccination when possible

o       Administration of immune globulin (IG) on the response to varicella virus vaccine is unknown

o       immunocompromised person is inadvertently exposed to a person who has a vaccine-related rash, VZIG need not be administered

o       Avoid using salicylates for 6 weeks

o       Nonpregnant women who are vaccinated should avoid becoming pregnant for 1 month

o       Varicella virus vaccine may be considered for a nursing mother


Chickenpox

The Misunderstood Vaccine
 Varicella (chickenpox or VZ) is a disease that has a mild reputation that it does not deserve.  Yuppies and Generations X-ers have had “chickenpox parties” to intentionally expose their children to an infected child “to get it over with”.  True enough, the disease is generally mild and self-limited. Chickenpox is not the scourge of the modern age.

 However, VZ is a herpes virus and is a successful and complex organism, which modulates the immune system. This decreases the body’s ability to fight infections normally for a variable period of time.  It is not unusual to have lesions on all mucosal surfaces (i.e. eye, mouth, nose, ear, rectum, and vagina) and to have secondary bacterial infections.  Dehydration, pneumonia, infection of the brain tissue and balance organs is also common.  The skin lesions can develop into disfiguring scars.  50 -100 deaths per year occur in the US in normal children secondary to VZ. The annual cost of caring for children of normal health who contract chickenpox was $918 million in1993 (mostly missed work). You do not want to hear about the uncommon complications.


 

On the other hand, Varicella vaccine is an immunization that has a bad reputation it doesn’t deserve.  The urban myth surrounding the vaccine actually carries within it a kernel of truth. It is true varicella is a disease process that is worse in individuals less than one year of age greater than 15 years.  Avoidance of vaccination is based on the idea that if the immunity from vaccination wanes he/she will acquire more severe disease as an adult than he/she would as a child.

The vaccine has been used in Japan and Korea since 1988 with excellent success.  The studies in the U.S on duration of response to the vaccine are ongoing.  However, these studies indicate immunity appears to be long lasting and is probably permanent in the majority of patients. A booster may be required but that is being discovered that may be true for many vaccines. As to complications, the rule of thumb throughout all the literature is that the vaccine organism is much less likely to cause problems than the wild or “natural” infection.
The CDC and the American Academy of Pediatrics recommend it.  Some physicians hesitate to give it because it means more injections.  Financially and scientifically this is the best advice we can give you for your child at this time.

  To restate the case above: the bug has a good reputation it does not deserve, the vaccine has a bad reputation it does not deserve. Talk to your doctor about the chickenpox vaccine.
 

Northeast Indiana Pediatric Specialists, PC

Dr. Michael Dick & Dr. Todd Dillon
11123 Parkview Plaza Drive Suite 102
Fort Wayne, IN 46845
(260) 483-0688

 
http://www.med-web.com/nips/

nips@med-web.com