WASHINGTON, May 7, (RTRS):  Pieces of DNA from a pig virus were found in Merck & Co Inc’s vaccine against a diarrhea-causing infection, but US health officials said on Thursday there was no evidence of a risk to people.
DNA from the same virus was found in a rival GlaxoSmithKline Plc vaccine. Glaxo and the Food and Drug Administration in March urged doctors to suspend use of that vaccine, but there was no similar recommendation for Merck’s product.
The FDA will seek input on both vaccines, which fight rotavirus infection, at an advisory panel meeting on Friday.
Merck said the company’s preliminary testing found “very low levels” of DNA from porcine circovirus, or PCV, in its Rotateq vaccine.
“There is no evidence at this time that DNA from PCV causes any disease in humans,” Merck said in a statement.
The FDA said the number of virus DNA fragments in the Merck vaccine may be smaller than what has been found with Glaxo’s product, called Rotarix.
“FDA has no evidence to date that these findings pertaining to Rotarix and RotaTeq pose a safety risk. Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients and clinical experience with millions of patients,” the agency said in a statement.
Rotavirus vaccines have a troubled history. Wyeth’s Rotashield was pulled off the market in 1999 after it was linked with a rare but deadly bowel obstruction.
Merck’s tests found fragments of DNA from PCV1 and a related virus called PCV2. Tests of Glaxo’s vaccine found only DNA from PCV1.
Both types are common in pigs but neither is known to cause illness in humans, the FDA said. PCV2 is believed to cause post-weaning multisystemic wasting syndrome in young piglets, marked by diarrhea and an inability to gain weight.
FDA spokeswoman Shelly Burgess said the agency felt it was appropriate to hear from the advisory panel as officials consider future recommendations for both vaccines. The vaccines prevent infection with rotavirus, which can cause severe diarrhea and kills more than 500,000 infants each year, mostly in low- and middle-income countries.
When Glaxo announced the pig virus finding in March, the World Health Organization said the risks from rotavirus outweighed any potential risks from PCV. It did not recommend any change to use of the vaccine in developing countries.
Merck said it tested Rotateq for PCV after the Glaxo findings were announced in March and immediately shared results with the FDA.
“We remain confident in the safety profile and quality of Rotateq. Rotavirus vaccines are a major public health advance,” the company said.
In Glaxo’s case, the virus DNA was found by accident when the company ran checks using new molecular detection techniques. The virus had apparently been there since the vaccine was first developed.
Glaxo has said no safety issues were identified with Rotarix and the company is working to replace the cell bank and virus seeds used to make Rotarix.

Diaper rash: Procter & Gamble Co called reports that its new Pampers with Dry Max cause rashes and other skin irritations “completely false” as it aimed to contain a public relations threat to its biggest diaper innovation in 25 years.
The world’s largest household products company said on Thursday that Pampers has been the subject of “completely false rumors fueled by social media.”
The statement comes a day after the US Consumer Product Safety Commission said it launched a probe into the new diapers after some parents complained that they appeared to be the cause of rashes and chemical burns on their children. 
Pampers recently updated its Swaddlers and Cruisers diapers with a thinner, more absorbent technology, which P&G has called its biggest diaper innovation in 25 years. The company has said the product went through extensive testing.
“These rumors are being perpetuated by a small number of parents, some of whom are unhappy that we replaced our older Cruisers and Swaddlers products while others support competitive products and the use of cloth diapers,” said Pampers Vice President Jodi Allen in a statement. She added that some of those parents “specifically sought to promote the myth that our product causes ‘chemical burns.’”
The company said it has received fewer than two complaints about diaper rash for every one million diapers sold, which it said is average for its business.
For brands that run into trouble with a product that causes injuries, branding expert Robert Passikoff said “the rule of thumb is the two Cs — contrition and closure.”
But even if the claims are false, or no link can be proved between the injuries and the product, the brand may still suffer, he said.
“It doesn’t matter if it’s true or false, perception is everything,” said Passikoff, president of Brand Keys Inc, a brand and customer loyalty research consultancy. He said it is especially true when it comes to babies.
This is the “mother and father, the lion and lioness,” Passikoff said. “The kind of protective, emotional levels that get raised are such that even the most rational argument is not necessarily going to satisfy.”

Ski helmets: Despite concerns that the extra weight of a helmet could cause neck injuries during skiing and snowboarding accidents, that doesn’t seem to be the case, according to Canadian researchers. Although studies have indicated that ski helmets are protective, their value became a topic of debate after the death of actress Natasha Richardson following a skiing accident last year at Canada’s Mont Tremblant resort.
Richardson, 45, wasn’t wearing a helmet when she fell and hit her head but it was questioned whether a helmet would have saved her anyway.
For their study, the researchers from the Alberta Children’s Hospital at the University Calgary analyzed a decade’s worth of accidents involving snowboarders and skiers in Quebec.
In slightly more than a quarter of nearly 3,000 neck injuries, the injured person had worn a helmet during the mishap. By contrast, only about one-fifth of those who had sustained injuries below the neck had worn one.
The researchers said that at first glance, the results would suggest that using a helmet ups the odds of causing damage to the neck but when accounting for other factors, such as skill, terrain and weather conditions, the increased risk disappeared.
This held true even in young children, whose disproportionately large heads would make them extra susceptible to neck injuries.
“To our knowledge, this is the largest study to have examined the effect of helmet use on neck injuries in skiers and snowboarders,” the researchers wrote in their study published in the American Journal of Epidemiology.
“Our study provides additional evidence that helmets do not significantly increase the risk of neck injuries among skiers and snowboarders, and their use should be encouraged.”
The National Ski Areas Association, a US trade association, promotes helmets, and several lawmakers are currently considering mandating their use.