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article imageFDA Approves New Rotavirus Vaccine

By T.A.Torrence     Apr 29, 2008 in Health
In a public statement on April 3rd, the GlaxoSmithKline Pharmaceuticals announced the release of Rotarix, the third oral vaccine for rotavirus to be developed. The FDA approved the vaccine on February
Rotavirus is a virus that causes gastroenteritis, stomach and intestinal inflammations, in children, causing severe dehydration due to vomiting and diarrhea. In the United States, rotavirus affects approximately 80% of the approximately 4 million infants born each year, around 2.7 million in the U.S. On an annual basis, about 500,000 of those infants require medical attention and 55,000 to 70,000 are hospitalized with 20 and 60 deaths. Furthermore, 125 million cases of diarrhea are attributed to rotavirus worldwide each year and causes an estimated 25% of all deaths due to diarrheal disease and 6% of all deaths in children under the age of five.
The vaccine was developed by Avant Immunotherapeutics and GlaxoSmithKline with final testing at the end of 2004. The product is being launched by investments from the Paul Royalty Fund II, L.P. (“PRF”) in 2005 for a share of the net royalties from the sale of the vaccine. PRF contributed a total of about $60 million to the product launch. It is estimated rotavirus costs the United States alone over $1 billion in direct medical and indirect societal costs.
During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.
Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline stated, “Among children less than five years of age in the U.S. who are hospitalized due to rotavirus symptoms, approximately one in five is younger than six months of age,”she continued, “With only two doses, ROTARIX allows infants to complete the vaccination series against rotavirus earlier than ever before, which may prevent many of the emergency department visits and hospitalizations that are a burden on families and the healthcare system.”
The first rotavirus vaccine was licensed in 1998. The vaccine, Rotashield, produced by Wyeth, was voluntarily pulled from the market in 1999, after it was discovered that the vaccine may have contributed to an increased risk of bowel obstruction in one of every 12,000 vaccinated infants.
Due to the association with bowel obstruction, AvantImmune and GlaxoSmithKline conducted a study of more than 63,000 infants. In that study, there was no increase in the risk of bowel obstruction in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants). Though there were Increased rates of convulsion and pneumonia-related deaths observed in the study, these events were not observed in other studies conducted by the manufacturer. The FDA concluded that the available data does not establish that these events are related to the vaccine, but the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.
The second vaccine, called RotaTeq was approved in February 2006 by the U.S. Food and Drug Administration for use in the United States. In August 2006, Health Canada approved RotaTeq for use in Canada. It was developed by Merck Corporation.
Rotarix is the third to be developed, but is currently one of two vaccines on the market. Both vaccines may be started at six weeks of age, however, Rotateq is a three dose vaccine, while Rotarix is a two dose allowing it to complete it's schedule and provide protection at an earlier age.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.
The CDC updated their 2008 schedule on March 5th, after the new vaccine was approved.
More about Rota virus, Gastroenteritis, Rotarix, Fda
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