Updated Rotavirus Vaccine Recommendations
Rotarix® Vaccine Use Can Be Resumed
From: Vermont Department of Health
Date: May 18, 2010
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The U.S. Food and Drug Administration (FDA) has revised its recommendation for use of rotavirus vaccines for the prevention of the disease in infants. It has determined that it is appropriate for health care professionals to resume the use of Rotarix® and to continue the use of RotaTeq®.
Within the last two months, FDA became aware of the presence of porcine circovirus (PCV) 1 in Rotarix® and DNA from PCV1 and PCV2 in RotaTeq®. The agency reached its decision after a careful evaluation of laboratory information from manufacturers and FDA’s own laboratories and a thorough review of scientific literature. It also received input from the FDA’s Vaccines and Related Biological Products Advisory Committee. In announcing its decision, the FDA noted that is considered the following:
- Both vaccines have strong safety records, including clinical trials with tens of thousands of patients as well as experience with millions of vaccine recipients.
- The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause disease in humans.
- The benefits of the vaccine are substantial. Prior to use of rotavirus vaccine, each year in the U.S. rotavirus was responsible for 55,000-70,000 hospitalizations and 20-60 deaths.
Vermont Specific Information on Administration and Ordering
In Vermont, Rotarix® is the rotavirus vaccine selected for use in the Vaccines for Children Program. Although RotaTeq® has been ordered for many practices during the temporary suspension, effective immediately Rotarix® will once again be the only rotavirus vaccine for order. In order to avoid wastage, please use your current supplies of Rotarix® and RotaTeq® before ordering more rotavirus vaccine.
ACIP recommends that the rotavirus vaccine series be completed with the same product whenever possible. However, vaccination should not be deferred because the product used for a previous dose(s) is not available or unknown. If any dose in the series was RotaTeq® or the vaccine product is not known, for any dose in the series, a total of three doses of rotavirus vaccine should be administered. All doses should be administered by age 8 months, 0 days.
If you have any questions, please contact the Immunization Program at firstname.lastname@example.org or call 1 (800) 464-4343, ext 7368.
Related Health Advisory:
Use of Rotarix Vaccine Temporarily Suspended for Non-Safety Reasons (3/10)