FDA Cautions Against Usage of Rotarix Rotavirus Vaccine
The Food and Drug Administration (FDA) has issued an advisory to doctors and parents to stop giving the Rotarix rotavirus vaccine to children until the federal scientists can confirm that it is safe.
Though Rotarix, manufactured by GlaxoSmithKline, prevents extreme cases of rotavirus infection that causes severe diarrhea and dehydration in infants, yet it contains a pig virus, porcine circovirus 1 or PCV1, which is known as not harmful to humans. However, as a precautionary measure, the FDA has issued the warning and advised parents and doctors not to use the vaccine until it is confirmed as safe for humans.
In the meantime, the FDA has recommended using Merck manufactured vaccine, RotaTeq. This vaccine is considered safe no trace of PCV1 has so far been found in this vaccine in the preliminary tests.
Rotavirus causes over 500,000 infant deaths throughout the world each year. In 2006, before RotaTeq was introduced in the United States, about 50,000 infants had to be hospitalized for Rotavirus.
Many of the US kids, vaccinated against rotavirus, have received RotaTeq and an estimated 1 million of them have received Rotarix, which was introduced in 2008.
The FDA is trying to determine whether Rotarix contains intact PCV1 or only viral traces. It is expected to form an expert advisory committee for further recommendations.
In 2009, the sale of the vaccine amounted to $425 million worldwide, including $115 million in the United States.
