The US Food and Drug Administration (FDA) has reported that stocks of Merck's Rotateq vaccine against rotavirus are contaminated with the pig viruses PCV1 and PCV2. But the agency has not advised doctors to stop using it as the pig viruses aren't known to cause disease in humans, and rotavirus kills roughly half a million infants worldwide each year. An FDA advisory panel said the vaccine's benefits still outweigh its risks.
The FDA plans to monitor recipients for pig virus-related illness. "There will be quite careful monitoring of the people that have received the vaccine and I think that's entirely appropriate," says virologist Stephen Hughes, who advised the FDA on the issue.
http://www.newscientist.com/article/mg20627603.100-baby-vaccine-contaminated-with-pig-virus.htmlBenefits of Contaminated Rotavirus Vaccine Outweigh Risks, Says FDA Panel May 7, 2010 — A majority of an advisory committee for the US Food and Drug Administration (FDA) today voiced support for the continued use of a contaminated rotavirus vaccine now under FDA suspension, arguing that the vaccine's benefits far outweigh the theoretical risks of the contaminant.
However, members of the Vaccines and Related Biological Products Advisory Committee also recommended studies of possible long-term risks of the vaccine in question, GlaxoSmithKline's Rotarix. . . .
Representatives of GlaxoSmithKline told the advisory committee today that the company is committed to ridding Rotarix of PCV1, but that it would take several years to do so, considering the complexities of the manufacturing process.
While the advisory panel did not find PCV1 to be any kind of short-term threat to humans, various members expressed apprehensive about PCV2, a contaminant in RotaTeq. Gordon Allan, PhD, a professor at The Queens University Belfast in Belfast, Northern Ireland, rang an alarm bell with what resembled a passing remark about how the virus triggers postweaning multisystemic wasting syndrome.
"PCV2 in a lot of ways is a strange virus," Dr. Allan said. To get "good disease in pigs with PCV2," one must infect them with the virus and then stimulate their immune system, either by reinfecting them with the virus or vaccinating them. He raised the possibility of this chain of events occurring with sequential doses of rotavirus vaccine.
Dr. John Coffin also advocated for more study of PCV2. "I have some nervousness about that one as well," he said.
http://www.medscape.com/viewarticle/721465Merck Vaccine Recalled in Hong Kong, to Remain in Use in U.S. Health authorities in Hong Kong on Friday ordered the recall of rotavirus vaccine contaminated by a pig virus, though members of an advisory panel of the U.S. Food and Drug Administration said the vaccine did not appear to create health risks and should still be used.
The Rotateq vaccine recalled in Hong Kong is made by Merck and is one of two U.S.-approved rotavirus vaccines. The recall comes two months after the FDA recommended that doctors suspend use of the other rotavirus vaccine, GlaxoSmithKline’s Rotarix, because it was found to be contaminated by the porcine virus. Now more sensitive tests have turned up pig virus in the Merck vaccine, too.
Without a virus-free vaccine to choose from, members of the FDA advisory panel said that use of the vaccines should continue because the benefits outweigh the risks. The pig virus is not known to cause human illness, and rotavirus can cause severe diarrhea and is responsible for the deaths of thousands of infants each year, particularly in developing countries.
Officials in Hong Kong described the recall as a precautionary measure in response to quality control issues involving the Rotateq vaccine.
http://www.fairwarning.org/2010/05/merck-vaccine-recalled-in-hong-kong-to-remain-in-use-in-u-s/