FDA Tells Docs to Resume Rotavirus Vaccinations

Rotarix, RotaTeq Deemed Safe, Despite Presence of DNA from Porcine Virus

May 17, 2010 03:05 pm News Staff

The FDA has again revised its recommendations for rotavirus vaccines, advising physicians to resume using Rotarix or continue using RotaTeq.

In March, the agency called for a temporary halt to the use of Rotarix after DNA from porcine circovirus type 1, or PCV1, was found in the vaccine, which is manufactured by GlaxoSmithKline.

Subsequent tests found that DNA from PCV1 and PCV2 were present in Merck and Co.'s Rotateq vaccine.

The FDA's Vaccines and Related Biological Products Advisory Committee met May 7 to discuss the issue.

In a May 14 press release(www.fda.gov), the FDA said it has found no evidence that PCV1 and PCV2 pose a safety risk to humans, and neither is known to cause infection or illness in humans. The agency said the known benefits of the vaccines, which have strong safety records, outweigh the risks.

According to the CDC, rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Before the rotavirus vaccine was introduced in the United States in 2006, rotavirus infection was responsible for between 55,000 and 70,000 hospitalizations and dozens of deaths each year.

"The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA's own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts," FDA officials said in the news release.

The agency said it is working with both GlaxoSmithKline and Merck to update the labeling for the vaccines to include information about the presence of PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq.

Merck said in a May 14 statement that it is working to identify the source of the PCV DNA and remove it from the vaccine.

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