FDA panel recommends continued use of Rotarix and RotaTeq vaccines despite viral DNA contamination

Key Points

Despite known contamination with porcine circovirus type 1 (PCV1), an FDA advisory panel recently agreed that Rotarix (GlaxoSmithKline) and RotaTeq (Merck), two approved vaccines to prevent rotavirus infection, should continue to be used.

Back on March 22, 2010, FDA formally recommended that healthcare providers suspend the use of Rotarix. This recommendation was a direct result of tests identifying the presence of viral DNA from PCV1 in the vaccine, as well as the working cell bank and viral "seed" used to produce all Rotarix.

The initial discovery of PCV1 components in Rotarix was made in early February 2010, by a group of independent US academic researchers who applied a new technology for detecting viral genetic material. Since that time, FDA and the manufacturers of the vaccine have confirmed the presence of DNA from PCV1 in the vaccine, consulted with experts on PCV1, and communicated with the World Health Organization and regulatory drug agencies in other countries.

Similarly, Merck researchers detected "very low levels" of PCV1 and PCV2 DNA in RotaTeq and shared the results with FDA, according to Merck and FDA.

The findings from Merck suggest that the number of PCV DNA fragments in its vaccine may be smaller than what has been found in Rotarix, according to a May 6, 2010 statement on FDA's website.

"There is no evidence at this time that DNA from PCV causes any disease in humans," said a statement posted on Merck's website. "We remain confident in the safety profile and quality of RotaTeq."

Rotavirus is linked to more than half a million infant deaths around the world each year, primarily in low- and middle-income countries. According to the Centers for Disease Control and Prevention (CDC), the disease caused more than 50,000 hospitalizations and dozens of deaths in the United States annually prior to the introduction of vaccine.

SOURCES

1. FDA. Rotarix vaccine: Update to clinicians and public health professionals. March 22, 2010. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm. Accessed March 23, 2010.

2. FDA. Early communication on Rotarix vaccine. Available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm205540.htm. Accessed March 23, 2010.

3. FDA. Vaccines, Blood & Biologics. Vaccines and Related Biological Products Advisory Committee Meeting Background Material. Porcine Circovirus and Rotavirus Vaccines. May 6, 2010. Available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm211101.htm. Accessed May 10, 2010.