Infant Rotavirus Vaccine Rotarix Contaminated: FDA Warns

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GlaxoSmithKline’s Rotarix vaccine, which is given to infants to inoculate them against the rotavirus, may be contaminated with viral DNA that should not be there and federal regulators are warning pediatricians not to use the vaccine.

The FDA issued the Rotarix warning on Monday, recommending that health care practitioners stop using the vaccine until the agency further examines the situation. However, the agency indicates that there is no evidence at this time that the extraneous viral DNA found in the vaccines poses a safety risk to infants.

The FDA says that an independent U.S. academic research team discovered genetic material from the porcine circovirus 1 (PVC1) in Rotarix. The FDA then confirmed through it’s own tests that extraneous viral DNA was in Rotarix. However, the virus is not known to cause illness in humans, the FDA stated.

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Rotarix is an oral vaccine given to infants six weeks or older to prevent rotavirus, which can cause vomiting, diarrhea and fever. Most adults are protected against rotavirus due to immunities acquired during childhood, and it is generally considered to be most dangerous among children two years old and younger.

The first rotavirus vaccine, Merck & Co.’s RotaTeq, was approved in 2006, and GlaxoSmithKline’s Rotarix was approved in 2008. About 55,000 children were hospitalized annually in the United States due to rotavirus before the vaccinations began.

“We are making clinicians aware of information recently received by FDA about the Rotarix vaccine,” said Dr. Margaret A. Hamburg, Commissioner for Food and Drugs. “There is no evidence at this time that there is a safety concern. FDA is recommending that clinicians temporarily suspend use of Rotarix until we can learn more about the situation. We will keep the public and the clinical community updated on our findings.”

Beyond the warning, FDA is taking no action at this time. However, the agency announced it will hold an expert advisory committee meeting and determine what other recommendations should be made.

Tags: Children, GlaxoSmithKline, Vaccine

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5 Comments

Celine
Hi, now in 2014, my 3 month old baby girl received the rotarix vaccinaton. Two to three days later she started cramping, had loads of noise in her belly and her bowel movements disminished enormously. She has flatulences, but no poo comes out almost and she is very fussy. Please anyone, have your babies since then recovered? Are their bowel movements regular again and your babies ok now? I would feel better knowing how similar cases evolved if you have good news.
Stephanie
March 4th 2011, my son received this rotarix vaccine at 3 months old; it was the worse thing we could have ever given him. He almost died, and lost his intestines. He had intussusception, which is caused by the vaccine, more common in males. It caused his small and large intestines to slide inside of each other and seal off. This made him bleed out. After a doctor visit, Hospital testing, and then an ER visit, they figured it out. Thank God, his bowels reversed. Otherwise it would have been death. He is now 13 months old, and still has bowel problems. His stool tests positive for blood. I wish we never gave him this vaccine. After research I found out most of the vaccines for the rotavirus has been recalled. The money this vaccine has caused us from doctor visits, hospital, ER, and special formula has cost a fortune. My son will probably never be the same. I truly regret this experience for my son; his life will never be the same.
Liz
My 5 month old twins got the rotarix vaccine, and had no ill effects from it at all. I am also pleased to report that one of them recently contracted a stomach virus (aged 11months), was sick once, had a mild fever, and was back to normal within half a day. His brother didn’t get it at all. This made a refreshing change from the usual vomiting every hr for 24hrs, and persistent diarrhoea I experienced when my older, unvaccinated children had the virus as infants. Dehydration is such a concern in small babies, that I think the vaccine is a brilliant option. These drugs have to pass stringent safety tests before being allowed onto the market, I for one am pleased that the option is there for my kids.
Gigi
My baby had Rotarix administered when he was exactly three months old. It has been 22 days and only on 4 has he had normal bowel movements. He has not been able to defecate without medication for the last 16 days. When I let him go on without medication for as long as three days several times, he was not able to pass stool. The company tells me it is not Rotarix but my baby never had such a problem before the vaccination, not even for a day.
Amber
After my 2 month old got The Rotarix Vaccine she has not had another normal bowel movement, it has been 9 weeks of constipation for her!And she only has bowel movements 1 every two days that is not normal!She is not the only baby that has had these symptoms right after the vaccine was administered.

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