I do not recommend this vaccine because it can cause diarrhea almost as often as the chances of
catching the disease.  Plus there are reports of it causing Kawasaki Disease which is quite severe.
I only have one infant in 3 years ever in the hospital for Rotovirus and if I look at the risk/benefit
ratio it just does not make sense to give it.  If parents want it they can get it at the county
health clinics.

 

Rotavirus to be next vaccine recommended for routine immunization

The vaccine will be administered to infants at 2 months, 4 months and 6 months of age.

by Cassandra A. Richards

 

PHILADELPHIA - A vaccine for protection against the most common cause of severe childhood diarrhea is expected to be the next vaccine recommended for routine use. The vaccine is awaiting approval by the Food and Drug Administration (FDA). The FDA Advisory Committee on Vaccines and Related Biological Rotavirus Products in December unanimously recommended approval of the vaccine (RotaShield, Wyeth-lederle) for the treatment of rotavirus infection.

If approved for marketing clearance, the live. tetravalent vaccine will be administered by mouth to infants at 2 months, 4 months and 6 months of age. Based oil the Clinical trials, the vaccine is compatible with other routine vaccines including Haemophilus influenzae type b, diphtetanus-pertussis and oral polio vaccines

ACIP recommendation

The anticipation of the vaccine's approval by the FDA, the Advisory Committee on Immunization Practices (ACIP) recommended in February that rotavirus vaccine be added to the recommended childhood immunization schedule pending approval.

The ACIP agreed that the safety and efficacy data indicated the vaccine can be given with routine immunizations, but voted against a recommendation for routine administration of the vaccine for premature infants defined as infants born at less than 37 weeks gestation.

The ACIP will complete wording of, the formal recommendation upon the vaccine's approval.

Results from a national multicenter trial, which enrolled more than 1,200 infants, indicated the vaccine was 49% effective against rotavirus episodes, 80% effective against very severe infection and 100% effective against dehydration associated with rotavirus infection. The vaccine also protected against 82% of A dehydrating diarrhea, according to the study by Margaret Rennels, MD, and colleagues.

A two-year study observed over 1,000 Navajo, Apache and Pima infants. The results indicated the vaccine was effective in preventing 50% of all rotavirus cases and 69% of severe cases when the vaccine was administered to infants using the schedule listed above.

A recent study conducted in Finland enrolled more than 2,300 infants between 2 months and 7 months of age. The results indicated the oral vaccine prevented 91% of severe rotavirus induced diarrhea, 96% of outpatient clinic visits and 100% of hospitalizations due to rotavirus.

Rotavirus results in 55,000 hospitalizations in children under 5 years and 500,000 physician visits annually in the United States; approximately 125 U.S. children die each year from the disease.

The vaccine was developed through a cooperative agreement between Wyeth-Ayerst and the National Institute of Allergy and Infectious Diseases

(NIAID) The vaccine consists of a mixture of four viruses that together protect against the four most prevalent clinical strains of rotavirus.