Rotavirus vaccine re-enters market after ban

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http://www.cnn.com/2004/HEALTH/05/04/rotavirus.vaccine.reut/index.html

Rotavirus vaccine reenters market after ban

Tuesday, May 4, 2004 Posted: 4:36 PM EDT (2036 GMT)

WASHINGTON (Reuters) -- A new company has agreed to market a vaccine

to fight rotavirus, five years after it was pulled off the market for

fears it could cause a sometimes-deadly bowel obstruction, U.S.

health officials said Tuesday.

Biovirx, Inc., of Minneapolis, Minnesota, will take the RotaShield

vaccine through the necessary steps to get it approved again and

market it, the National Institutes of Health said.

" The NIH has identified a new commercialization partner for the

RotaShield product that was previously marketed by Wyeth , " said Dr.

Mowatt, who helps organize agreements between NIH researchers

and industry.

RotaShield was approved in the United States in 1998 to prevent

rotavirus infections, which kill nearly 600,000 children and cause

more than 135 million episodes of diarrhea a year around the world.

" The virus is the leading cause of serious diarrheal illness in U.S.

infants, and in the developing world, babies commonly die of

rotavirus infection, " the National Institute of Allergy and

Infectious Diseases said in a statement.

But after a million U.S. infants were vaccinated, RotaShield, which

is given orally, was found to cause a rare type of bowel obstruction

called intussusception.

The Advisory Committee on Immunization Practices, a panel of

vaccination experts that helps the U.S. government set vaccine

policy, withdrew its advice that infants get the vaccine. Wyeth had

already withdrawn the vaccine voluntarily.

" Clearly it was a cause of intussusception, " said Dr. Offit of

the Children's Hospital of Philadelphia and an ACIP member.

But the NIH said studies have since shown that perhaps the vaccine

did not cause as many cases of the potentially deadly bowel problem

as had been at first thought.

Case count discrepancy

" It's never been the NIAID's position that the vaccine was

dangerous, " Mowatt said in a telephone interview.

Leonard Ruiz, president and chief executive of Biovirx, said he

thought there would be a good market for the vaccine in the United

States and globally, despite the controversy over the pulled vaccine.

" Today we know that it is a completely safe vaccine when used

properly, " Ruiz said in a telephone interview. He said when given to

infants at age 2 months it did not cause any extra cases of

intussusception.

Offit said the NIH, where the vaccine was developed, disagreed with

the U.S. Centers for Disease Control and Prevention over how many

cases of intussusception were actually caused by the vaccine.

One study suggested there were some children who were already

susceptible to the condition, but that the vaccine somehow provoked

it earlier.

In the United States, where diarrheal disease is easily treated,

perhaps the risks of the vaccine do not outweigh the benefits, Offit

said. In the developing world, he said, the vaccine clearly would

save many lives.

But he said he believed parents and doctors alike would resist any

reintroduction of the vaccine.

" Would RotaShield have been a benefit in this country? I think it

would have been, " said Offit, who is advising Merck and Co. on its

development of a new rotavirus vaccine. GlaxoKline is also

working on one.

Offit took part in a World Health Organization meeting in 2000 at

which developing countries were offered the vaccine or its technology

free of charge by Wyeth. " Country after country said if it is not

safe for U.S. children it is not safe for our children, " he said.