FDA Lifts Suspension of Rotavirus Vaccines

Nearly two months ago, the FDA recommended doctors avoid using the popular rotavirus vaccine Rotarix after it was found to have a pig virus contaminant. The recommendation has been lifted after an advisory panel decided the benefits of the vaccine far outweighed the potential risks. More than 500,000 infants die every year all around the world as a result of being infected with the rotavirus. Rotavirus causes severe diarrhea and other dangerous gastro issues.

Rotarix is a fairly new vaccine, approved in 2008. It is manufactured by GlaxoSmithKline. Very few children in the United States were given the Rotarix vaccine. The FDA reiterated the fact that there were no known dangerous side effects, but they simply wanted to do a thorough investigation into the contaminant. Once the investigation was opened, scientists discovered the vaccine RotaTeq manufactured by Merck & Co also contained the pig virus. The findings related to the Merck virus were not released to the public because the panel had already made their decision about the use of the vaccines.

The possibility of a human being infected by the pig virus was deemed as theoretical and posed no serious risks. The panel’s reasoning was based on the decline in deaths and hospitalizations related to rotavirus since the first vaccine was introduced. Before the vaccine was introduced in 2006, 70,000 infants were hospitalized in the US as a direct result of the rotavirus.  Both vaccines have impressive safety records and doctors are being told to continue to use them as part of a regular vaccination schedule.