FDA Revises Recommendations for Rotavirus Vaccines

Information for Parents and Caregivers
Rotavirus causes severe diarrhea and dehydration in young infants. There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. Each of these vaccines is given by mouth in a series of doses during the first year of life.

Within the last two months, FDA became aware of the presence PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq. These viruses are not known to cause any infection or illness in people.

Based on a careful review of a variety of scientific information, FDA has determined it is appropriate for clinicians and public health professionals in the United States to use these vaccines. All available evidence supports the safety and effectiveness of Rotarix and RotaTeq, which have been extensively studied, both before and after approval.

Are the rotavirus vaccines safe to give to my child?
Yes, both vaccines have a successful track record of safety and effectiveness. FDA has evaluated laboratory results from testing performed by the manufacturers and in its own laboratories. Based on a careful evaluation of these results, a thorough review of the scientific literature, and input from scientific and public health experts, FDA has no evidence that either PCV1 or PCV2 poses a safety risk. Neither PCV1 nor PCV2 is known to cause infection or illness in people. The benefits of the vaccines for infants are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. The patient information for Rotarix and RotaTeq is posted on FDA’s web site.

My child received the rotavirus vaccine. Should I be worried?
No. Both vaccines have strong safety records, including clinical studies involving tens of thousands of patients and millions of recipients following approval. Neither PCV1 nor PCV 2 is known to cause infection or illness in people. Children who received Rotarix or RotaTeq vaccines need no additional medical follow-up.

Was FDA's March 22, 2010, recommendation to temporarily suspend use of the vaccine due to safety concerns?
No. Based on what we know, the presence of PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq is not a safety issue. Neither PCV1 nor PCV2 is known to cause infection or illness in people. FDA and the manufacturers are continuing to investigate and evaluate these findings.

Additional Information for Healthcare Providers and Public Health Professionals

What information is available to share with parents about the findings of PCV or PCV DNA in rotavirus vaccines?
Based on careful evaluation of a variety of scientific information, FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the U.S. and of death in other parts of the world.

I have a supply of either Rotarix or RotaTeq vaccine in my medical practice. Can I use it?
Yes, FDA has determined it is appropriate for clinicians and public health professionals in the United States to use these vaccines.

Is there any medical follow-up needed for children who have received the Rotarix or RotaTeq vaccine?
FDA does not believe medical follow-up is warranted for children who have been vaccinated with Rotarix and RotaTeq vaccines. Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine. While the agency learned more about the situation, FDA made the recommendation to temporarily suspend the use of Rotarix.

Will the prescribing information be updated to reflect the presence of PCV and PCV DNA in the vaccines?
FDA is working with both vaccine manufacturers (GlaxoSmithKline and Merck) to update the labeling for both Rotarix and RotaTeq vaccines to include information about the presence of PCV1 (Rotarix) and DNA from PCV1 and PCV2 (RotaTeq) in the vaccines. The patient labeling will also be revised to include this information. FDA is also working with the Centers for Disease Control and Prevention to update the Vaccine Information Statement for rotavirus vaccines.

Was FDA's recommendation to temporarily suspend use of Rotarix due to safety concerns?
No. FDA made the recommendation while the agency learned more about the situation. Based on what we know at the current time, the presence of PCV and PCV DNA is not a safety risk. FDA has no evidence that either PCV1 or PCV2 poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. In addition, both rotavirus vaccines have strong safety records.