Costa Rica’s Health Ministry OKs use of rotavirus vaccine recalled in U.S.
April 7th, 2010 | by admin |Costa Rica’s Ministry of Health announced on March 26 that it is maintaining its plans to include routine rotavirus immunizations with the oral Rotarix vaccine as part of the country’s mandatory vaccine regimen within the next few months.
On March 22 the U.S. Food and Drug Administration temporarily recalled the Rotarix vaccine until research into the presence of Porcine circovirus 1 (PCV-1) fragments found in the doses is completed. The vaccine is used against the rotavirus, which can cause severe diarrhea and vomiting. Both the agency and the vaccine’s producers, GlaxoSmithKline (Glaxo), believe the PCV-1 fragments pose no threat to human health since the virus is not associated with illness in humans. Furthermore, the viral fragments were in the vaccine during its successful clinical trials.
Just before its release two years ago, the Rotarix vaccine also came under scrutiny due to an increase in pneumonia deaths in clinical studies. At that time, the Reuters press agency reported that Glaxo failed to disclose this to the FDA because of the higher death rates from respiratory infections occured in Latin America.
According to the Pan-American Health Organization (PAHO), the vaccine, which offers protection over two seasons, is especially important in tropical countries such as Costa Rica where children are exposed to the virus year-round. The clinical trials for Rotarix were, in fact, based largely on a Latin American sample. According to PAHO, the majority of children under the age of five come in contact with one of several strains of rotavirus. However, children in tropical climates have an earlier onset of infection, making them more at risk for dehydration from diarrhea and vomiting than children in temperate countries.
Dr. Hilda Bolanos at the Costa Rican Nutrition and Health Research Institute (INCIENSA) said that the rotavirus vaccine “has proven effectiveness in minimizing severe cases of diarrhea and deaths associated with rotavirus,” but also added that the vaccine should not be seen as a substitute for hand washing, breast feeding, good nutrition, ample water intake, and other practices that can help minimize infections and mitigate the effects of diarrhea in young children.
The most recent Centers for Disease Control rotavirus data estimates that in Costa Rica 170 children under five died from diarrhea in 2003, with 43 of the deaths attributed to rotavirus.
Glaxo’s Rotarix generated over $420 million in sales last year. It competes with Merck’s RotaTeq, which has been on the market since February 2006.
