The Food and Drug Administration (FDA) recommends that healthcare practitioners temporarily suspend use of the Rotarix vaccine for rotavirus immunization in the United States while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk.

Routine testing of Rotarix vaccine by an independent U.S. academic research team detected PCV1 genetic material (Porcine Circovirus 1) in the vaccine. PCV1 is not known to cause illness in humans or other animals. Rotarix has been studied extensively and found to have an excellent safety record. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix.

This temporary suspension will enable further evaluation of the vaccine by the FDA and CDC while not losing its efficacy.

Vaccine Storage and Handling:

Isolate the Rotarix vaccine while maintaining the proper cold chain in anticipation of the cancellation of the suspension.

Do not return or discard the vaccine.

It is important to note:The vaccine is effective.

Children who completed the 2 dose series are considered protected.

There is no need to re-administer any Rotarix doses.

If the Rotarix vaccine series has not been completed, complete the series with 2 doses of RotaTeq at the appropriate intervals.

There is no need to test children who received the vaccine.

 

The FDA press release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm. The FDA has established a website with information regarding the rotavirus vaccine at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm205585.htm#hcpFDA. This website will provide updates as more information becomes available from the FDA.

Contact Laura Rutledge for questions regarding vaccine recommendations and Robert Griffin regarding vaccine orders and inventory at (850) 245-4342. Florida Department of Health