Temporary suspension of Rotarix – a rotavirus vaccine for kids

By Dr. Ananya Mandal, MDMar 23 2010

The US FDA after deliberation has come up with a warning to the nation’s pediatricians to stop giving children a vaccine that prevents diarrhea causing Rotavirus vaccine. There is reportedly a contamination with a harmless pig virus in this vaccine called Rotarix and manufactured by GlaxoSmithKline.

The contaminating virus in Rotarix is called porcine circovirus type 1 or PCV-1. This is not known to cause disease.

"PCV-1 does not multiply in humans and is not known to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resulting disease or illness," the company said in a statement on Monday

“This was a difficult decision for us because there is no evidence at this time that there is a risk to children,” said Dr. Margaret Hamburg, the Food and Drug Administration commissioner.

Rotavirus Diarrhea

Rotavirus usually causes severe watery diarrhea in children that may lead to dehydration and even death. The WHO reports nearly 500,000 deaths each year world wide and 50,000 hospitalizations in USA alone due to this deadly virus. These vaccines are usually given by mouth to children at two and three months of age.

What now?

An alternative brand called RotaTeq from Merck is available at present that can be safely given to children.

Over 1 million children in USA and 30 million children world wide have already been vaccinated with Rotarix. However Dr. Hamburg says that doctors or parents need not worry about any adverse effects in children already vaccinated.

“We’re not taking this vaccine off the market,” Dr. Hamburg said. “We’re simply asking that there be a pause in its use.”

History of Rotavirus vaccine

Rotavirus vaccine has been surrounded by controversies and adverse effects right from their inception in 1998 with RotaSheild from Wyeth. This vaccine was purported to cause bowel obstruction or intussuseption in infants and was subsequently withdrawn from market.

Benefit vs Risk

“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, said in a written statement.

Hamburg stressed that the suspension applies only to the United States. Public health officials in countries where the incidence of rotavirus is more severe may decide that the benefits of continuing to use the vaccine outweigh any concerns raised by the contamination, she said. "Such a decision would be very understandable," she added.

A similar virus, porcine circovirus 2, also does not cause disease in humans, but it does cause disease in its pig host, Hamburg said.

The FDA said its vaccine advisory committee would meet within the next four to six weeks to review the issue.

Expert speak

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said "a substantial amount" of the DNA was found in the vaccine. But, he stressed, "there is no evidence that it causes any disease. ... There is no evidence that it ever does anything."