May 17, 2010

US FDA Reaffirms Safety of Rotavirus Vaccines

On May 14, 2010, the US Food and Drug Administration (FDA) revised its recommendation to temporarily suspend use of the Rotarix® rotavirus vaccine.  In an updated statement, the FDA advised health care providers in the US to resume use of Rotarix® and continue use of RotaTeq^TM, noting the strong safety record of both vaccines and that “the benefits of the vaccines, which are known, outweigh the risk, which is theoretical.”

In March, FDA had temporarily suspended use of Rotarix®, in order to further investigate findings of porcine circovirus DNA fragments within the vaccine. At that time, the FDA—as well as the European Medicines Agency and the World Health Organization—concluded that porcine circovirus did not pose a public health risk. WHO advised that rotavirus vaccines should continue to be used, particularly in high-burden settings.

On May 7, 2010, experts of the FDA’s Vaccines and Related Biological Products Advisory Committee met to review available data and confirmed initial conclusions that the vaccines pose no safety risk. 

While rotavirus occurs worldwide, developing countries suffer the greatest burden, with more than half a million children dying every year due to severe infections and limited access to emergency medical care. Recent publications in the New England Journal of Medicine showed a substantial reduction in deaths of Mexican children due to diarrheal disease after the introduction of Rotarix®, and in clinical trials in impoverished, high-mortality communities in Africa, the vaccine significantly reduced severe rotavirus disease in African infants.

The PATH Rotavirus Vaccine Trials Partnership is a collaboration between PATH, WHO, the US CDC, clinical study sites, and vaccine manufacturers. The partnership’s activities are funded by the GAVI Alliance.