Q&A on Rotarix® Vaccine for Healthcare Providers and Public Health Professionals

Vaccines and Preventable Diseases:
Q&A on Rotarix® Vaccine for Healthcare Providers and Public Health Professionals


What is happening with Rotarix® (rotavirus vaccine)?
The Food and Drug Administration (FDA), which approves and monitors vaccines to ensure their safety and effectiveness, has found pieces of a non-harmful porcine circovirus (originally found in healthy pigs) called porcine circovirus type 1 (PCV1) in the GlaxoSmithKline vaccine called “Rotarix®.” PCV1 is not known to cause disease in people or animals.

The FDA is recommending that healthcare providers temporarily stop using this vaccine in children until further studies are done. There is another brand of rotavirus vaccine called “RotaTeq®.” Most children vaccinated in the United States have received RotaTeq®. Experts are looking closely at the RotaTeq® vaccine also, and so far, no porcine circovirus type 1 has been found.

Was FDA's recommendation to temporarily suspend use of the Rotarix® vaccine due to safety concerns?
Based on what we know at the current time, the presence of porcine circovirus type 1 (PCV1) is not a safety issue. PCV1 is not known to cause disease in humans or animals. FDA and the manufacturer are in the process of obtaining additional information to assess whether this finding impacts the quality of the vaccine.

Did any children get sick from the porcine circovirus type 1 (PCV1) in this vaccine?
No children appear to have gotten sick or been harmed by the porcine circovirus type 1 (PCV1) in this vaccine. The type of circovirus found is not known to cause disease in people or animals.

I have a supply of Rotarix® in my medical practice. What should I do with it?
FDA recommends that clinicians temporarily suspend the administration of Rotarix® until the temporary hold on vaccination with Rotarix® is lifted. Because new recommendations are expected in four to six weeks, clinicians should keep Rotarix® stored at the correct temperature for possible future use.

Should I send it back to the manufacturer?
Since this is a temporary suspension of the use of Rotarix®, the product should not be returned. GlaxoSmithKline (GSK) will provide updates to customers directly. Customers with questions should call the GSK Response Center at 888-825-5249.

Can I use it until my supply runs out?
Use of Rotarix® is not prohibited, but FDA has recommended that healthcare providers temporarily suspend its use. The manufacturer (GlaxoSmithKline) has suspended distribution, and CDC has suspended ordering.

CDC recognizes that clinical decisions in the best interest of patients must be determined by the clinician (e.g., knowing you may not have the opportunity for follow-up vaccination or may completely lose the chance to vaccinate a child).

Is there any medical follow up needed for children who have received the Rotarix® vaccine?
No. FDA does not believe medical follow up is warranted for children who have been vaccinated with Rotarix®. Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine. FDA’s recommendation to temporarily halt the use of Rotarix® is a precaution taken while more is learned about the situation.

Will FDA’s recommendation that clinicians temporarily suspend using Rotarix® lead to a shortage of rotavirus vaccine in the United States?
FDA does not anticipate significant shortages of rotavirus vaccine in the United States. RotaTeq® represents the majority of the rotavirus vaccine market in the United States. Preliminary testing of RotaTeq® by both academic researchers and FDA scientists has not detected components of porcine circovirus type 1 (PCV1).

If a child has received one dose of Rotarix®, what should I do for the next dose?
For children who have received one dose of Rotarix®, the Centers for Disease Control and Prevention advises that clinicians can complete the series with RotaTeq® for the next two doses. Because RotaTeq® is given as a 3-dose series, a total of 3 doses (including 1 dose of Rotarix®) are needed for a child to be fully vaccinated against rotavirus.

How can I find out more?
FDA will keep healthcare providers and public health professionals updated on its review of the situation.

What can I tell parents?
Resources for parents about rotarix can be found at Parents & Caregivers: Q&A About the Rotarix®.

When talking to parents emphasize:

- encourage parents to complete the rotavirus vaccination series as appropriate;
the safety of vaccines and remind parents that the benefits of vaccines greatly outweigh any risks;

- no disease has been associated with these components of viral DNA in humans or animals;

- in the U.S, a million or more children have been safely vaccinated with Rotarix® already, and millions more with RotaTeq®;

- this is not in any way related to the voluntarily withdrawal of RotaShield®, which was a different vaccine;

- this is not related to eating pork products;

- vaccine safety is held to the highest standards;

- your child’s health and safety are of concern; rotavirus is less severe in the United States than in other countries, and vaccines have helped reduce the severity and amount of disease we see here.
http://www.cdc.gov/vaccines/vpd-vac/rotavirus/rotarix-providers.htm