DNA of Pig Viruses Found in Merck and Glaxo Vaccine

DNA of Pig Viruses Found in Merck Vaccine

WSJ May 7,2010
WASHINGTON-The Food and Drug Administration said Thursday that fragments of two types of pig viruses were found in Merck & Co.'s Rotateq vaccine, but the agency didn't immediately say whether the vaccine should be avoided.                                                        Only a parody
An FDA vaccine-advisory panel had already scheduled a meeting for Friday to discuss GlaxoSmithKline PLC's Rotarix vaccine. Both the Glaxo and Merck vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies. Rotavirus is rarely fatal in the U.S.
FRIDAY UPDATE: FDA Panel Members Back Use Of Merck, Glaxo Rotavirus Vaccines
A Food and Drug Administration panel said Friday fragments of pig viruses found in vaccines used to protect infants against rotavirus didn't appear to cause health risks. While the panel didn't take a vote on the products, several members of the agency's vaccine panel said the vaccines -- Merck & Co.'s (MRK) Rotateq and GlaxoSmithKline PLC's (GSK, GSK.LN) Rotarix -- should remain on the U.S. market while additional studies are conducted about the impact of pig viruses.
In the meantime, the panel said parents who are considering whether to vaccinate their infants need to be informed about the findings.

DNA of Pig Viruses Found in Merck Vaccine

WASHINGTON—The Food and Drug Administration said Thursday that fragments of two types of pig viruses were found in Merck & Co.'s Rotateq vaccine, but the agency didn't immediately say whether the vaccine should be avoided.

An FDA vaccine-advisory panel had already scheduled a meeting for Friday to discuss GlaxoSmithKline PLC's Rotarix vaccine. Both the Glaxo and Merck vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies. While rotavirus is rarely fatal in the U.S., it contributed to about 70,000 infant hospitalizations annually before Merck's vaccine was approved in 2006 and Glaxo's in 2008.

One of the pig-virus types found in the Merck vaccine is the same one found in Glaxo's Rotarix vaccine in March. At the time, the FDA recommended that doctors stop using that vaccine and use Merck's Rotateq, even though the agency said it didn't think the virus fragments posed safety risks to humans. Both vaccines are designed to protect infants from a gastrointestinal illness caused by rotavirus and have been given to millions of babies since Merck's Rotateq vaccine was approved for use in the U.S. in 2006. Glaxo's competing vaccine was approved for use in the U.S. in 2008; either vaccine is given to babies along with other routine childhood vaccines.