Rotarix is a vaccine used to protect children from rotaviruses, viral infections that affect the digestive tract and lead to severe diarrhea in babies and young children. The vaccine that is meant to protect children is now being halted. The U.S. Food and Drug Administration has asked doctors to stop using the Rotarix vaccine while investigations are conducted.
The drug has been found to be contaminated with traces of a second virus, called PCV-1. This is a DNA virus that infects pigs and other species, however, is not known to cause illness in humans or other types of animals. This second virus comes from the cell cultures that are used to make Rotarix.
The FDA has stated that there is no evidence to suggest it poses a safety risk to children. In fact, it has not even been pulled off the market, just temporarily suspended. The next step is for the FDA and scientists to determine how the virus got into the vaccine and what it was doing. Until further studies done, doctors will not be permitted to use the Rotarix vaccine.
Rotarix is a liquid suspension of the live, thin strain of human rotavirus made by GlaxoSmithKline. It was licensed in 2008. The drug helps prevent rotavirus gastro-enteritis in children, which affects their digestive system. This vaccine works by exposing the child to a tiny dose of the virus, enabling the body to develop immunity to the rotavirus disease.
Rotarix cannot treat rotavirus; it only serves to protect from the virus. So if the body has an active infection it will not help. This vaccine is given in two oral doses to children who are between the ages of 6 weeks and 32 weeks old.
The effects of rotavirus include vomiting and watery diarrhea. It is one of the more serious infections for infants across the world, causing around 500,000 deaths every year. In the United States the number of deaths is significantly less, around 100. However, the rotavirus was still responsible for about 50,000 pediatric hospitalizations each year before the vaccine started to be used.
If you or a loved one has experienced health complications or illness while using Rotarix or related drugs, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.